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system safety engineer mid level or senior
Electrical Technician
QAI Laboratories Inc Cleveland, Ohio
QAI JOB NUMBER: QAI-ELEMC- JOB TITLE: Technician I NUMBER OF POSITIONS: 1 LOCATION: Middleburg Heights, Ohio DEPARTMENT: ELE & EMC BACKGROUND: Founded in 1995 by a group of experienced certifications and testing experts, QAI Laboratories Ltd. (QAI) is a multi-national professional certification body, test laboratory, and inspection agency with offices throughout North America and Asia. Recognition of the QAI name and logo have grown significantly over the past few years resulting in significant expansion of the business. At QAI, we live and breathe our mission statement: to provide reliable conformity assessments and market access while maintaining the trust of society. We're always striving to be the go-to source for conformity assessments through our commitment to knowledge, excellent service, and continual development, as stated in our vision statement. QAI has an exciting career opportunity within the testing department . We are currently seeking an experienced Technician to support the ELE and EMC Department at our Middleburg Heights, Ohio location. This role involves Electrical Product Safety and Electromagnetic Compatibility (EMC) testing, supporting compliance evaluations, data analysis, and reporting for a wide range of products to ensure they meet regulatory and safety standards. DUTIES : The successful candidate will perform, but not be limited to, the following duties: ELE Read, understand, organize, and execute testing programs for a variety of different material and assembly evaluations. Have the ability to read and interpret various electrical safety standards (CSA, UL, IEC, etc.).Liaison with QAI account managers and clients to ensure appropriate testing and timelines to meet client expectations and goals. Work independently to ensure completion of testing, reporting and certification programs. Observe QAI Quality Management Systems and best work practices. Present professional and friendly work environment for QAI clients and fellow staff. General lab duties including clean up, organizing, material procurement as required. Lab equipment maintenance and construction of test fixtures.Duties as assigned by management. EMC Perform testing of equipment to recognized standardsRecord and analyze test dataUnderstand technical result from relevant equipment (such as spectrum analyzers, oscilloscopes, signal generators, radio frequency amplifiers, chart recorders etc.)Write concise and accurate test reports:Interpret technical instructions and log sheets including maintaining a log of reports and update management of project status as neededEnter test data using Microsoft Office and other programs.Write clear and concise language that is responsive to requirements.Interact effectively with clients and staffWork with Program Managers to incorporate customer editsWork collaboratively with engineers and other subject matters expert to understand the operation and application of all products and services that are being documentedMaintain test equipment and track calibration recordsEnsure work complies with the QAI quality systemOther duties as assigned by the manager or its designee QUALIFICATIONS : The successful candidate will: Minimum Have a technician / trade school diploma / two or more years degree or equivalent directly related experience. Possess the ability to read, understand, and apply technical Electrical Safety & EMC standards towards product testing programsPossess "Good Laboratory Practice" skills essential for testing products.Possess strong analytical skillsPossess good interpersonal and communication skills, both written and oralPossess ability to work effectively within the team while under tight deadlines Possess superior MS Word and Excel skills and be proficient with email correspondence KEY TECHNICAL COMPETENCE: Accepts instruction and follows it for testing outside of their general scope of knowledge and experience.Able to grasp general concepts in a field of testing and apply it to specific test methods.Able to perform testing and as knowledge grows in a specific field of testing graduates to more complex testing methods.Seeks assistance and knowledge from more senior personnel when a specific requirement is outside of their general scope ofknowledge.Good working knowledge of the test methods in their specific discipline.Able to multi-task with some degree of efficiency and accuracy.Maintains a sense of ownership and responsibility for projects assigned to them. ADDITIONAL INFORMATION: Candidates must hold a valid driver's license (willingness to travel as needed). Candidates must be open to working extended hours during peak service demands. Join our Team! Learn, Develop, Grow! At QAI, you will have the opportunity to put your aptitude, experience, knowledge, and desire to learn to the test. We make a difference in people's lives through the work we do as a top-notch Product Testing, Certification, and Inspection body whilst providing rewarding careers for our employees. Equal Opportunity Employer QAI Laboratories is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, marital status, political affiliation, sexual orientation, gender identity, genetic information, disability or protected veteran status. We are committed to providing a workplace free of any discrimination or harassment. NOTE : No sponsorship is available. PI030cc654f5ec-2432
12/06/2025
Full time
QAI JOB NUMBER: QAI-ELEMC- JOB TITLE: Technician I NUMBER OF POSITIONS: 1 LOCATION: Middleburg Heights, Ohio DEPARTMENT: ELE & EMC BACKGROUND: Founded in 1995 by a group of experienced certifications and testing experts, QAI Laboratories Ltd. (QAI) is a multi-national professional certification body, test laboratory, and inspection agency with offices throughout North America and Asia. Recognition of the QAI name and logo have grown significantly over the past few years resulting in significant expansion of the business. At QAI, we live and breathe our mission statement: to provide reliable conformity assessments and market access while maintaining the trust of society. We're always striving to be the go-to source for conformity assessments through our commitment to knowledge, excellent service, and continual development, as stated in our vision statement. QAI has an exciting career opportunity within the testing department . We are currently seeking an experienced Technician to support the ELE and EMC Department at our Middleburg Heights, Ohio location. This role involves Electrical Product Safety and Electromagnetic Compatibility (EMC) testing, supporting compliance evaluations, data analysis, and reporting for a wide range of products to ensure they meet regulatory and safety standards. DUTIES : The successful candidate will perform, but not be limited to, the following duties: ELE Read, understand, organize, and execute testing programs for a variety of different material and assembly evaluations. Have the ability to read and interpret various electrical safety standards (CSA, UL, IEC, etc.).Liaison with QAI account managers and clients to ensure appropriate testing and timelines to meet client expectations and goals. Work independently to ensure completion of testing, reporting and certification programs. Observe QAI Quality Management Systems and best work practices. Present professional and friendly work environment for QAI clients and fellow staff. General lab duties including clean up, organizing, material procurement as required. Lab equipment maintenance and construction of test fixtures.Duties as assigned by management. EMC Perform testing of equipment to recognized standardsRecord and analyze test dataUnderstand technical result from relevant equipment (such as spectrum analyzers, oscilloscopes, signal generators, radio frequency amplifiers, chart recorders etc.)Write concise and accurate test reports:Interpret technical instructions and log sheets including maintaining a log of reports and update management of project status as neededEnter test data using Microsoft Office and other programs.Write clear and concise language that is responsive to requirements.Interact effectively with clients and staffWork with Program Managers to incorporate customer editsWork collaboratively with engineers and other subject matters expert to understand the operation and application of all products and services that are being documentedMaintain test equipment and track calibration recordsEnsure work complies with the QAI quality systemOther duties as assigned by the manager or its designee QUALIFICATIONS : The successful candidate will: Minimum Have a technician / trade school diploma / two or more years degree or equivalent directly related experience. Possess the ability to read, understand, and apply technical Electrical Safety & EMC standards towards product testing programsPossess "Good Laboratory Practice" skills essential for testing products.Possess strong analytical skillsPossess good interpersonal and communication skills, both written and oralPossess ability to work effectively within the team while under tight deadlines Possess superior MS Word and Excel skills and be proficient with email correspondence KEY TECHNICAL COMPETENCE: Accepts instruction and follows it for testing outside of their general scope of knowledge and experience.Able to grasp general concepts in a field of testing and apply it to specific test methods.Able to perform testing and as knowledge grows in a specific field of testing graduates to more complex testing methods.Seeks assistance and knowledge from more senior personnel when a specific requirement is outside of their general scope ofknowledge.Good working knowledge of the test methods in their specific discipline.Able to multi-task with some degree of efficiency and accuracy.Maintains a sense of ownership and responsibility for projects assigned to them. ADDITIONAL INFORMATION: Candidates must hold a valid driver's license (willingness to travel as needed). Candidates must be open to working extended hours during peak service demands. Join our Team! Learn, Develop, Grow! At QAI, you will have the opportunity to put your aptitude, experience, knowledge, and desire to learn to the test. We make a difference in people's lives through the work we do as a top-notch Product Testing, Certification, and Inspection body whilst providing rewarding careers for our employees. Equal Opportunity Employer QAI Laboratories is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, marital status, political affiliation, sexual orientation, gender identity, genetic information, disability or protected veteran status. We are committed to providing a workplace free of any discrimination or harassment. NOTE : No sponsorship is available. PI030cc654f5ec-2432
Hydrogeologist
Montgomery & Associates Oakland, California
Hydrogeologist Montgomery & Associates (M&A) is seeking a full-time hydrogeologist or groundwater hydrologist to join our California Team. The position includes mid-level responsibilities and requires the ability to manage and provide technical support to multiple tasks and/or projects simultaneously. The person in this position will interact with M&A team leaders, project staff, project managers, administrative personnel, clients, and regulators. Our company of highly respected water resources professionals, headquartered in Tucson, Arizona, has been in business since 1984 and is growing, with recent expansions in the western U.S. and South America. In California, our team comprises 21 professional staff across 4 offices: Oakland, Sacramento, Monterey, and Pasadena. This position will support groundwater resource and environmental projects throughout California. The role offers an exciting opportunity to work with an enthusiastic team of water resource scientists and engineers. The position is available at 3 of our California offices (Oakland, Sacramento, or Monterey). Our team is currently working at least 50% in the office. Work duties will include the following: Managing and technically contributing to tasks and projects that focus on quantitative hydrogeology and groundwater resources management, including: Supporting projects planning and implementation of the Sustainable Groundwater Management Act (SGMA) Interpretation of lithologic, hydrologic testing, depth-specific water quality, and borehole geophysical data Designing and interpreting results of predictive modeling runs and supporting model updates Evaluating and filling hydrogeologic data gaps Developing hydrogeologic conceptual models Developing water budgets Designing and managing field investigations Interacting with field teams to implement monitoring programs Data evaluations and preparation of technical reports Preparing technical proposals and work plans for future work Qualifications: Graduate degree in hydrology, geology, or engineering or professional registration (P.G. or P.E.). Both preferred. Understanding of groundwater principles Clear understanding of how to apply hydrogeologic principles to characterize and assess groundwater systems Four to 10 years of experience in environmental and water resources consulting Task or project management experience Working knowledge of geographic information systems (ArcGIS), Survey123, and SQL and Access databases preferred Professional experience working with groundwater models and stratigraphic modeling software preferred Experience working on SGMA projects for local Groundwater Sustainability Agencies preferred Professional experience with groundwater sampling, remedial investigations, and remediation technologies a plus Strong organizational, troubleshooting, and problem-solving skills, and ability to meet deadlines Proficiency with standard analytical approaches and tools Demonstrated technical writing skills and ability to present technical information in group/meeting settings, and to clients Team-oriented and experienced with delegating work to staff and reviewing staff deliverables Interest in engaging in professional organizations, including presenting at conferences Ability to legally work and reside in the United States Your benefits at Montgomery & Associates will include: Competitive benefits and salary in an expanding team-oriented company Dynamic work environment with safety and technical training provided by the company Interesting and collaborative multidisciplinary projects On the job mentoring by senior professionals Medical, dental, and vision insurance Flexible Spending Account; HRA Long- and short-term disability Life/AD&D insurance Vacation, holiday, personal, and sick leave Employer matching 401k retirement plan Monthly Base Pay Range: $6,750 - $8,850 Estimated Annualized Compensation Including Bonuses: $91,000 - $120,000 Compensation for qualified extra hours could further increase the estimate above. We are an Equal Opportunity Employer M&A values diversity and inclusivity. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, sex, gender, gender identity, gender expression, age, sexual orientation, religious creed, physical or mental disability, medical condition, genetic information, marital status, veteran status, or any other classification protected by applicable federal, state, or local law. PI0d699aa293c1-4281
12/01/2025
Full time
Hydrogeologist Montgomery & Associates (M&A) is seeking a full-time hydrogeologist or groundwater hydrologist to join our California Team. The position includes mid-level responsibilities and requires the ability to manage and provide technical support to multiple tasks and/or projects simultaneously. The person in this position will interact with M&A team leaders, project staff, project managers, administrative personnel, clients, and regulators. Our company of highly respected water resources professionals, headquartered in Tucson, Arizona, has been in business since 1984 and is growing, with recent expansions in the western U.S. and South America. In California, our team comprises 21 professional staff across 4 offices: Oakland, Sacramento, Monterey, and Pasadena. This position will support groundwater resource and environmental projects throughout California. The role offers an exciting opportunity to work with an enthusiastic team of water resource scientists and engineers. The position is available at 3 of our California offices (Oakland, Sacramento, or Monterey). Our team is currently working at least 50% in the office. Work duties will include the following: Managing and technically contributing to tasks and projects that focus on quantitative hydrogeology and groundwater resources management, including: Supporting projects planning and implementation of the Sustainable Groundwater Management Act (SGMA) Interpretation of lithologic, hydrologic testing, depth-specific water quality, and borehole geophysical data Designing and interpreting results of predictive modeling runs and supporting model updates Evaluating and filling hydrogeologic data gaps Developing hydrogeologic conceptual models Developing water budgets Designing and managing field investigations Interacting with field teams to implement monitoring programs Data evaluations and preparation of technical reports Preparing technical proposals and work plans for future work Qualifications: Graduate degree in hydrology, geology, or engineering or professional registration (P.G. or P.E.). Both preferred. Understanding of groundwater principles Clear understanding of how to apply hydrogeologic principles to characterize and assess groundwater systems Four to 10 years of experience in environmental and water resources consulting Task or project management experience Working knowledge of geographic information systems (ArcGIS), Survey123, and SQL and Access databases preferred Professional experience working with groundwater models and stratigraphic modeling software preferred Experience working on SGMA projects for local Groundwater Sustainability Agencies preferred Professional experience with groundwater sampling, remedial investigations, and remediation technologies a plus Strong organizational, troubleshooting, and problem-solving skills, and ability to meet deadlines Proficiency with standard analytical approaches and tools Demonstrated technical writing skills and ability to present technical information in group/meeting settings, and to clients Team-oriented and experienced with delegating work to staff and reviewing staff deliverables Interest in engaging in professional organizations, including presenting at conferences Ability to legally work and reside in the United States Your benefits at Montgomery & Associates will include: Competitive benefits and salary in an expanding team-oriented company Dynamic work environment with safety and technical training provided by the company Interesting and collaborative multidisciplinary projects On the job mentoring by senior professionals Medical, dental, and vision insurance Flexible Spending Account; HRA Long- and short-term disability Life/AD&D insurance Vacation, holiday, personal, and sick leave Employer matching 401k retirement plan Monthly Base Pay Range: $6,750 - $8,850 Estimated Annualized Compensation Including Bonuses: $91,000 - $120,000 Compensation for qualified extra hours could further increase the estimate above. We are an Equal Opportunity Employer M&A values diversity and inclusivity. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, sex, gender, gender identity, gender expression, age, sexual orientation, religious creed, physical or mental disability, medical condition, genetic information, marital status, veteran status, or any other classification protected by applicable federal, state, or local law. PI0d699aa293c1-4281
Hydrogeologist
Montgomery & Associates Sacramento, California
Hydrogeologist Montgomery & Associates (M&A) is seeking a full-time hydrogeologist or groundwater hydrologist to join our California Team. The position includes mid-level responsibilities and requires the ability to manage and provide technical support to multiple tasks and/or projects simultaneously. The person in this position will interact with M&A team leaders, project staff, project managers, administrative personnel, clients, and regulators. Our company of highly respected water resources professionals, headquartered in Tucson, Arizona, has been in business since 1984 and is growing, with recent expansions in the western U.S. and South America. In California, our team comprises 21 professional staff across 4 offices: Oakland, Sacramento, Monterey, and Pasadena. This position will support groundwater resource and environmental projects throughout California. The role offers an exciting opportunity to work with an enthusiastic team of water resource scientists and engineers. The position is available at 3 of our California offices (Oakland, Sacramento, or Monterey). Our team is currently working at least 50% in the office. Work duties will include the following: Managing and technically contributing to tasks and projects that focus on quantitative hydrogeology and groundwater resources management, including: Supporting projects planning and implementation of the Sustainable Groundwater Management Act (SGMA) Interpretation of lithologic, hydrologic testing, depth-specific water quality, and borehole geophysical data Designing and interpreting results of predictive modeling runs and supporting model updates Evaluating and filling hydrogeologic data gaps Developing hydrogeologic conceptual models Developing water budgets Designing and managing field investigations Interacting with field teams to implement monitoring programs Data evaluations and preparation of technical reports Preparing technical proposals and work plans for future work Qualifications: Graduate degree in hydrology, geology, or engineering or professional registration (P.G. or P.E.). Both preferred. Understanding of groundwater principles Clear understanding of how to apply hydrogeologic principles to characterize and assess groundwater systems Four to 10 years of experience in environmental and water resources consulting Task or project management experience Working knowledge of geographic information systems (ArcGIS), Survey123, and SQL and Access databases preferred Professional experience working with groundwater models and stratigraphic modeling software preferred Experience working on SGMA projects for local Groundwater Sustainability Agencies preferred Professional experience with groundwater sampling, remedial investigations, and remediation technologies a plus Strong organizational, troubleshooting, and problem-solving skills, and ability to meet deadlines Proficiency with standard analytical approaches and tools Demonstrated technical writing skills and ability to present technical information in group/meeting settings, and to clients Team-oriented and experienced with delegating work to staff and reviewing staff deliverables Interest in engaging in professional organizations, including presenting at conferences Ability to legally work and reside in the United States Your benefits at Montgomery & Associates will include: Competitive benefits and salary in an expanding team-oriented company Dynamic work environment with safety and technical training provided by the company Interesting and collaborative multidisciplinary projects On the job mentoring by senior professionals Medical, dental, and vision insurance Flexible Spending Account; HRA Long- and short-term disability Life/AD&D insurance Vacation, holiday, personal, and sick leave Employer matching 401k retirement plan Monthly Base Pay Range: $6,750 - $8,850 Estimated Annualized Compensation Including Bonuses: $91,000 - $120,000 Compensation for qualified extra hours could further increase the estimate above. We are an Equal Opportunity Employer M&A values diversity and inclusivity. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, sex, gender, gender identity, gender expression, age, sexual orientation, religious creed, physical or mental disability, medical condition, genetic information, marital status, veteran status, or any other classification protected by applicable federal, state, or local law. PI1bb33b11cee2-3799
12/01/2025
Full time
Hydrogeologist Montgomery & Associates (M&A) is seeking a full-time hydrogeologist or groundwater hydrologist to join our California Team. The position includes mid-level responsibilities and requires the ability to manage and provide technical support to multiple tasks and/or projects simultaneously. The person in this position will interact with M&A team leaders, project staff, project managers, administrative personnel, clients, and regulators. Our company of highly respected water resources professionals, headquartered in Tucson, Arizona, has been in business since 1984 and is growing, with recent expansions in the western U.S. and South America. In California, our team comprises 21 professional staff across 4 offices: Oakland, Sacramento, Monterey, and Pasadena. This position will support groundwater resource and environmental projects throughout California. The role offers an exciting opportunity to work with an enthusiastic team of water resource scientists and engineers. The position is available at 3 of our California offices (Oakland, Sacramento, or Monterey). Our team is currently working at least 50% in the office. Work duties will include the following: Managing and technically contributing to tasks and projects that focus on quantitative hydrogeology and groundwater resources management, including: Supporting projects planning and implementation of the Sustainable Groundwater Management Act (SGMA) Interpretation of lithologic, hydrologic testing, depth-specific water quality, and borehole geophysical data Designing and interpreting results of predictive modeling runs and supporting model updates Evaluating and filling hydrogeologic data gaps Developing hydrogeologic conceptual models Developing water budgets Designing and managing field investigations Interacting with field teams to implement monitoring programs Data evaluations and preparation of technical reports Preparing technical proposals and work plans for future work Qualifications: Graduate degree in hydrology, geology, or engineering or professional registration (P.G. or P.E.). Both preferred. Understanding of groundwater principles Clear understanding of how to apply hydrogeologic principles to characterize and assess groundwater systems Four to 10 years of experience in environmental and water resources consulting Task or project management experience Working knowledge of geographic information systems (ArcGIS), Survey123, and SQL and Access databases preferred Professional experience working with groundwater models and stratigraphic modeling software preferred Experience working on SGMA projects for local Groundwater Sustainability Agencies preferred Professional experience with groundwater sampling, remedial investigations, and remediation technologies a plus Strong organizational, troubleshooting, and problem-solving skills, and ability to meet deadlines Proficiency with standard analytical approaches and tools Demonstrated technical writing skills and ability to present technical information in group/meeting settings, and to clients Team-oriented and experienced with delegating work to staff and reviewing staff deliverables Interest in engaging in professional organizations, including presenting at conferences Ability to legally work and reside in the United States Your benefits at Montgomery & Associates will include: Competitive benefits and salary in an expanding team-oriented company Dynamic work environment with safety and technical training provided by the company Interesting and collaborative multidisciplinary projects On the job mentoring by senior professionals Medical, dental, and vision insurance Flexible Spending Account; HRA Long- and short-term disability Life/AD&D insurance Vacation, holiday, personal, and sick leave Employer matching 401k retirement plan Monthly Base Pay Range: $6,750 - $8,850 Estimated Annualized Compensation Including Bonuses: $91,000 - $120,000 Compensation for qualified extra hours could further increase the estimate above. We are an Equal Opportunity Employer M&A values diversity and inclusivity. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, sex, gender, gender identity, gender expression, age, sexual orientation, religious creed, physical or mental disability, medical condition, genetic information, marital status, veteran status, or any other classification protected by applicable federal, state, or local law. PI1bb33b11cee2-3799
BSI West
Technical Specialist - Microbiology (Colorado)
BSI West Aurora, Colorado
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
BSI West
Technical Specialist - Microbiology (Colorado)
BSI West Longmont, Colorado
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
BSI West
Technical Specialist - Microbiology (Colorado)
BSI West Englewood, Colorado
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
BSI West
Technical Specialist - Microbiology (Colorado)
BSI West Denver, Colorado
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
BSI West
Technical Specialist - Microbiology (Colorado)
BSI West
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
BSI West
Technical Specialist - Microbiology (Colorado)
BSI West Boulder, Colorado
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.
09/04/2020
Full time
Great that you're thinking about a career with BSI! Are you a Microbiologist, Sterilization Engineer, or Quality Manager looking for an interesting career change? Join our growing team! BSI hires qualified and experienced industry microbiologists to help clients navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing outlined under ISO 13485. This is a full-time position for a mid to senior-level professional with competitive salary, annual bonus, and great benefits. Due to notified body requirements, we cannot consider candidates with less than four years of post-graduate sterile medical device experience. This role is home-based in Colorado with travel to client sites so candidates must be located near a major airport. Essential Responsibilities: Responsible for planning, reporting and performing of audits of clients' management systems ensuring compliance with regulatory and voluntary requirements. Conduct comprehensive in-depth medical device reviews (including sterilization validation). These reviews will often be of devices that represent the cutting edge of knowledge and technology where no product standards or device experience exists, in these cases the job holder will draw on significant knowledge and experience to make a reasoned judgement on product safety. When working in this area it is essential that the job holder is competent to identify when additional specialist expertise is required and is capable to review such work. Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective. Develop proposals and plans for major client management, and project plan the launch of new devices through the regulatory process. Also responsible for negotiating effective utilization of resources to protect the integrity and accreditation of the approval process and deliver cost benefits to BSI and client. The Technical Specialist - Microbiology role requires maturity to make difficult decisions regarding the benefits and risks of medical device products and whether to recommend certification. The individual must be able to clearly and confidently communicate with clients. Please carefully review the qualifications listed below and apply if you meet the criteria. Education/Qualifications: A minimum of four (4) years' experience working as a microbiologist (or sterilization engineer) for a sterile medical device manufacturer (REQUIRED) Bachelor's degree in Microbiology, Biology or related scientific degree (REQUIRED) Thorough knowledge of ISO 13485 and ISO 9001 quality standards and familiarity with Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR) Ability to travel 60% via car and plane ISO 13485 Lead Auditor preferred Quality management experience including significant participation in third party quality audits Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business. BSI is an Equal Opportunity Employer and we are committed to diversity. To protect our candidates and BSI employees during the Covid-19 outbreak, all interviews will take place remotely.

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