Cleveland Diagnostics Inc.
Cleveland, Ohio
Quality Specialist Our team is growing, and we currently have an immediate opening for a Quality Specialist Title Quality Specialist Location Onsite-Cleveland Office Reports To Director of Quality Assurance Job Overview Participate in activities supporting the successful implementation and maintenance of the quality management system (QMS) in compliance with current ISO13485, EU IVDR, and 21 CFR 820 requirements. Create, review, and manage documentation related to the QMS. Participate in cGMP and quality related activities. Requires excellent attention to detail, critical thinking, risk-based decision making, communication, and a consistent quality minded approach. Essential Duties & Responsibilities Supplier Management: Support the supplier management process including related activities for qualification, audits, surveys, change control, corrective actions, and the approved supplier list (ASL). Internal Audit Program: Schedule and perform internal quality audits, assist in the resolution of audit findings, and manage the resulting records and supporting evidence. Batch Record Review: Perform comprehensive Quality review of completed batch records and associated production records. Corrective and Preventive Action (CAPA): Support identification and resolution of events, perform root cause investigation, determine corrective action plans, and facilitate on time closure. Deviations: Support identification and resolution of events, perform risk and impact assessment, implement immediate corrections, perform root cause investigation, determine corrective action plans, and facilitate on time closure. Documentation: Coordinate, manage, and perform quality review of controlled documents and records. 3rd Party Audits: Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Bodies, or registrars (ISO certification and surveillance audits). Nonconforming Product: Assist all departments to identify, investigate, document, and resolve nonconformity events. Change Control: Support the change control process to determine and address the potential risks and impact of changes to product design, materials, processes, systems, equipment, etc. This includes the management of associated records and supporting documentation. Training: Coordinate initial QMS training for new hires, assist all departments to manage employee training, and coordinate refresher training. Complaint Files: Support complaint records, perform root cause investigations, and determine corrective action plans. Quality Management Review: Support information gathering and analysis for the QMS management review process. Quality Oversight: Perform Quality checks of manufacturing activities including label verification, final release inspection, and records review. Continuous Improvement: Participate in the creation, revision, and implementation of procedures, forms, and work instructions to improve current processes. Prepare for and participate in QA-related activities. All other duties as assigned Working Relationships Interacts frequently with employees across and at all levels within the organization Collaboration expected to resolve identified issues and events Participates in cross-functional teams Does not have direct reports Work Environment / Physical Requirements: Bachelor's degree in a scientific discipline such as chemistry, biology, or engineering 4 years of experience in a Quality role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing Working knowledge and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR Working knowledge and experience with current good manufacturing practices (cGMP) and good documentation practices (GDocP) Excellent verbal and written communication skills Excellent computer proficiency with Microsoft Office products General office and HVAC noise - Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Cleveland Diagnostics offers an extremely robust benefits package which includes: 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage 100% Employer-paid Dental & Vision for entire family No cost for employee coverage for Group Term Life, Short & Long Term Disability 4% retirement contribution Employer match Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs) Paid Family Leave Program Generous PTO plan & holiday program Flexible work schedule & lucrative employee referral program Salary range may vary by work state/geographical region/territory Easy to get to office location with newly built-out office space Free coffee, snacks and other goodies all day long Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities. Compensation details: 0 PI402ffd3c6e92-4195
Quality Specialist Our team is growing, and we currently have an immediate opening for a Quality Specialist Title Quality Specialist Location Onsite-Cleveland Office Reports To Director of Quality Assurance Job Overview Participate in activities supporting the successful implementation and maintenance of the quality management system (QMS) in compliance with current ISO13485, EU IVDR, and 21 CFR 820 requirements. Create, review, and manage documentation related to the QMS. Participate in cGMP and quality related activities. Requires excellent attention to detail, critical thinking, risk-based decision making, communication, and a consistent quality minded approach. Essential Duties & Responsibilities Supplier Management: Support the supplier management process including related activities for qualification, audits, surveys, change control, corrective actions, and the approved supplier list (ASL). Internal Audit Program: Schedule and perform internal quality audits, assist in the resolution of audit findings, and manage the resulting records and supporting evidence. Batch Record Review: Perform comprehensive Quality review of completed batch records and associated production records. Corrective and Preventive Action (CAPA): Support identification and resolution of events, perform root cause investigation, determine corrective action plans, and facilitate on time closure. Deviations: Support identification and resolution of events, perform risk and impact assessment, implement immediate corrections, perform root cause investigation, determine corrective action plans, and facilitate on time closure. Documentation: Coordinate, manage, and perform quality review of controlled documents and records. 3rd Party Audits: Participate in QMS audits of Cleveland Diagnostics by regulators, customers, Notified Bodies, or registrars (ISO certification and surveillance audits). Nonconforming Product: Assist all departments to identify, investigate, document, and resolve nonconformity events. Change Control: Support the change control process to determine and address the potential risks and impact of changes to product design, materials, processes, systems, equipment, etc. This includes the management of associated records and supporting documentation. Training: Coordinate initial QMS training for new hires, assist all departments to manage employee training, and coordinate refresher training. Complaint Files: Support complaint records, perform root cause investigations, and determine corrective action plans. Quality Management Review: Support information gathering and analysis for the QMS management review process. Quality Oversight: Perform Quality checks of manufacturing activities including label verification, final release inspection, and records review. Continuous Improvement: Participate in the creation, revision, and implementation of procedures, forms, and work instructions to improve current processes. Prepare for and participate in QA-related activities. All other duties as assigned Working Relationships Interacts frequently with employees across and at all levels within the organization Collaboration expected to resolve identified issues and events Participates in cross-functional teams Does not have direct reports Work Environment / Physical Requirements: Bachelor's degree in a scientific discipline such as chemistry, biology, or engineering 4 years of experience in a Quality role within a US FDA regulated industry such as medical device or pharmaceutical manufacturing Working knowledge and experience with Quality Management Systems (QMS) such as 21 CFR 820, ISO13485, or EU IVDR Working knowledge and experience with current good manufacturing practices (cGMP) and good documentation practices (GDocP) Excellent verbal and written communication skills Excellent computer proficiency with Microsoft Office products General office and HVAC noise - Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Cleveland Diagnostics offers an extremely robust benefits package which includes: 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage 100% Employer-paid Dental & Vision for entire family No cost for employee coverage for Group Term Life, Short & Long Term Disability 4% retirement contribution Employer match Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs) Paid Family Leave Program Generous PTO plan & holiday program Flexible work schedule & lucrative employee referral program Salary range may vary by work state/geographical region/territory Easy to get to office location with newly built-out office space Free coffee, snacks and other goodies all day long Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities. Compensation details: 0 PI402ffd3c6e92-4195
Cleveland Diagnostics Inc.
Cleveland, Ohio
Senior Associate Scientist, IVD Test Dev We are seeking a Senior Associate Scientist-IVD Test Development to support in-vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR. Title: Senior Associate Scientist, IVD Test Development Location: On-site, Cleveland, Ohio Reports to: Sr Director, IVD Test Development Job Description: The Senior Associate Scientist will support in-vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR. This role requires strong hands-on technical skills, attention to detail, and the ability to follow established protocols while contributing to experimental planning and troubleshooting under the guidance of a supervisor. The Senior Associate Scientist will perform routine and non-routine laboratory procedures, analyze and summarize data, maintain accurate documentation in accordance with quality system requirements, and assist in preparing technical reports and study documentation. In addition to laboratory execution, this position will support lab organization, equipment maintenance, reagent preparation, and continuous improvement initiatives to ensure efficient study execution. The role involves handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies. Essential Duties and Responsibilities In collaboration with a supervisor, design and plan laboratory experiments with clearly defined objectives and success criteria. Independently execute laboratory experiments supporting assay development, optimization, verification, and validation in accordance with approved protocols and design control requirements. Provide technical input toward refinement of new diagnostic assays and improvements to existing assay workflows. Independently apply basic to intermediate statistical analyses to study results and ensure data accuracy and integrity. Prepare data summaries, figures, tables, and preliminary interpretations for internal technical review. Maintain complete, accurate, and GDP/QMS-compliant experimental records and documentation. Perform routine troubleshooting of assays, instrumentation, and laboratory workflows; escalate complex issues appropriately. Prepare reagents, solutions, and study materials while ensuring traceability and proper documentation. Demonstrate accountability for assigned workstreams, meeting study timelines, documentation standards, and data quality expectations. Coordinate with vendors and internal teams to procure laboratory supplies and maintain operational readiness. Actively participate in technical discussions, team meetings, and cross-functional reviews. Ensure compliance with all safety policies, biosafety procedures, laboratory standards, and company requirements. Other duties as assigned Qualifications/Requirements Bachelor's degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 2-4 years of relevant experience. Master's degree with 1-2 years of experience Industry experience preferable Technical Skills: Hands-on experience with standard laboratory techniques such as pipetting, reagent preparation, and handling. (Experience with automated immunochemistry analyzers preferred). Ability to follow standard protocols and troubleshoot routine lab tasks Experience with data analysis and documentation best practices Familiarity working in an FDA or ISO-regulated environment is a plus Proficient with computer skills and with Microsoft Office applications Physical Requirements/Working Conditions/Equipment Used: Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens, troubleshoot and repair instrumentation. Visual acuity to examine specimens and reagents Offices reachable by elevator but should be able to climb stairs if needed Light lifting may be required (up to 25 pounds) May be required to stand for long periods of time Ability to operate a computer and other technology related lab equipment through course of day Ability to work in an environment with exposure to hazardous chemicals and biohazards Ability to comply with all appropriate job PPE requirements General office and HVAC noise Other Requirements Full-time on-site position; this is not a remote position This position is classified as exempt and may require work in excess of 8 hours per day and/or 40 hours per week as business needs dictate May require infrequent travel Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples) Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Cleveland Diagnostics offers an extremely robust benefits package which includes: 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage 100% Employer-paid Dental & Vision for entire family No cost for employee coverage for Group Term Life, Short- & Long-Term Disability 4% retirement contribution Employer match Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs) Paid Family Leave Program Generous PTO plan & holiday program Flexible work schedule & lucrative employee referral program Salary range may vary by work state/geographical region/territory Easy to get to office location with newly built-out office space Free coffee, snacks and other goodies all day long Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities. Compensation details: 0 PI7564fbdc5ce9-7424
Senior Associate Scientist, IVD Test Dev We are seeking a Senior Associate Scientist-IVD Test Development to support in-vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR. Title: Senior Associate Scientist, IVD Test Development Location: On-site, Cleveland, Ohio Reports to: Sr Director, IVD Test Development Job Description: The Senior Associate Scientist will support in-vitro diagnostic assay development and validation activities within a regulated environment operating under design control. The successful candidate will execute laboratory experiments and contribute to assay optimization, verification, and validation studies in support of regulatory submissions including PMA, 510(k), and IVDR. This role requires strong hands-on technical skills, attention to detail, and the ability to follow established protocols while contributing to experimental planning and troubleshooting under the guidance of a supervisor. The Senior Associate Scientist will perform routine and non-routine laboratory procedures, analyze and summarize data, maintain accurate documentation in accordance with quality system requirements, and assist in preparing technical reports and study documentation. In addition to laboratory execution, this position will support lab organization, equipment maintenance, reagent preparation, and continuous improvement initiatives to ensure efficient study execution. The role involves handling human biological specimens, including blood, plasma, urine, and other bodily fluids, in compliance with all safety regulations and company policies. Essential Duties and Responsibilities In collaboration with a supervisor, design and plan laboratory experiments with clearly defined objectives and success criteria. Independently execute laboratory experiments supporting assay development, optimization, verification, and validation in accordance with approved protocols and design control requirements. Provide technical input toward refinement of new diagnostic assays and improvements to existing assay workflows. Independently apply basic to intermediate statistical analyses to study results and ensure data accuracy and integrity. Prepare data summaries, figures, tables, and preliminary interpretations for internal technical review. Maintain complete, accurate, and GDP/QMS-compliant experimental records and documentation. Perform routine troubleshooting of assays, instrumentation, and laboratory workflows; escalate complex issues appropriately. Prepare reagents, solutions, and study materials while ensuring traceability and proper documentation. Demonstrate accountability for assigned workstreams, meeting study timelines, documentation standards, and data quality expectations. Coordinate with vendors and internal teams to procure laboratory supplies and maintain operational readiness. Actively participate in technical discussions, team meetings, and cross-functional reviews. Ensure compliance with all safety policies, biosafety procedures, laboratory standards, and company requirements. Other duties as assigned Qualifications/Requirements Bachelor's degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 2-4 years of relevant experience. Master's degree with 1-2 years of experience Industry experience preferable Technical Skills: Hands-on experience with standard laboratory techniques such as pipetting, reagent preparation, and handling. (Experience with automated immunochemistry analyzers preferred). Ability to follow standard protocols and troubleshoot routine lab tasks Experience with data analysis and documentation best practices Familiarity working in an FDA or ISO-regulated environment is a plus Proficient with computer skills and with Microsoft Office applications Physical Requirements/Working Conditions/Equipment Used: Fine motor skills and manual dexterity to handle specimens and lab equipment required to process specimens, troubleshoot and repair instrumentation. Visual acuity to examine specimens and reagents Offices reachable by elevator but should be able to climb stairs if needed Light lifting may be required (up to 25 pounds) May be required to stand for long periods of time Ability to operate a computer and other technology related lab equipment through course of day Ability to work in an environment with exposure to hazardous chemicals and biohazards Ability to comply with all appropriate job PPE requirements General office and HVAC noise Other Requirements Full-time on-site position; this is not a remote position This position is classified as exempt and may require work in excess of 8 hours per day and/or 40 hours per week as business needs dictate May require infrequent travel Requires Hepatitis B vaccination or appropriate waiver (working with blood-based samples) Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics. Cleveland Diagnostics offers an extremely robust benefits package which includes: 100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage 100% Employer-paid Dental & Vision for entire family No cost for employee coverage for Group Term Life, Short- & Long-Term Disability 4% retirement contribution Employer match Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs) Paid Family Leave Program Generous PTO plan & holiday program Flexible work schedule & lucrative employee referral program Salary range may vary by work state/geographical region/territory Easy to get to office location with newly built-out office space Free coffee, snacks and other goodies all day long Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities. Compensation details: 0 PI7564fbdc5ce9-7424