Associate Director, Contract Management Role Overview: As Associate Director, Contract Management, you will oversee commercial contracting and administration, leading a high-performing team across the US and Costa Rica. The role requires strong collaboration with key commercial functions and oversight of contracts spanning capital, service, software, and disposables. Knowledge: In-depth understanding of contract management principles, policies, and processes. Familiarity with risk management, compliance standards, and relevant laws and regulations affecting contract administration. Knowledge of best practices in process improvement, data analytics, and contract tracking technologies. Awareness of industry trends, particularly within the Medical Device sector (preferred). Skills: Strategic thinking and vision-building, with the ability to formulate actionable plans and measurable outcomes. Advanced analytical skills for performance assessment and data-driven decision-making. Expertise in negotiating, drafting, and managing a wide range of commercial contracts. Proficiency in cross-functional collaboration and communication, translating complex ideas for diverse audiences. Strong leadership and coaching skills, with a proven ability to mentor and develop team members. Organizational skills to manage multiple priorities and allocate resources effectively in a fast-paced environment. Behaviors: Demonstrates proactive problem-solving and a continuous improvement mindset. Fosters a culture of professionalism, accountability, and ongoing development within the team. Maintains high standards of accuracy and quality, especially when working under time constraints. Actively listens and responds to stakeholder needs, identifying challenges and opportunities. Champions collaboration and partnership across departments to achieve shared business goals. Experience: Bachelor's Degree with 10+ years, or Master's degree with 8+ years of relevant experience in contract management, sales, pricing, finance, or related fields. Proven track record of strategic management and driving results in complex, matrixed organizations. Demonstrated experience developing and implementing contract management policies, process improvements, and compliance initiatives. Experience leading, mentoring, and developing teams within a commercial environment. Medical Device industry experience is preferred. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $129,600-216,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
12/05/2025
Full time
Associate Director, Contract Management Role Overview: As Associate Director, Contract Management, you will oversee commercial contracting and administration, leading a high-performing team across the US and Costa Rica. The role requires strong collaboration with key commercial functions and oversight of contracts spanning capital, service, software, and disposables. Knowledge: In-depth understanding of contract management principles, policies, and processes. Familiarity with risk management, compliance standards, and relevant laws and regulations affecting contract administration. Knowledge of best practices in process improvement, data analytics, and contract tracking technologies. Awareness of industry trends, particularly within the Medical Device sector (preferred). Skills: Strategic thinking and vision-building, with the ability to formulate actionable plans and measurable outcomes. Advanced analytical skills for performance assessment and data-driven decision-making. Expertise in negotiating, drafting, and managing a wide range of commercial contracts. Proficiency in cross-functional collaboration and communication, translating complex ideas for diverse audiences. Strong leadership and coaching skills, with a proven ability to mentor and develop team members. Organizational skills to manage multiple priorities and allocate resources effectively in a fast-paced environment. Behaviors: Demonstrates proactive problem-solving and a continuous improvement mindset. Fosters a culture of professionalism, accountability, and ongoing development within the team. Maintains high standards of accuracy and quality, especially when working under time constraints. Actively listens and responds to stakeholder needs, identifying challenges and opportunities. Champions collaboration and partnership across departments to achieve shared business goals. Experience: Bachelor's Degree with 10+ years, or Master's degree with 8+ years of relevant experience in contract management, sales, pricing, finance, or related fields. Proven track record of strategic management and driving results in complex, matrixed organizations. Demonstrated experience developing and implementing contract management policies, process improvements, and compliance initiatives. Experience leading, mentoring, and developing teams within a commercial environment. Medical Device industry experience is preferred. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $129,600-216,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency and Third-Party Recruiter Notice: Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Here at Hologic it is our purpose to enable healthier lives everywhere, every day. We are driven by our passion to become the global champion for women's health. We achieve this by fulfilling our promise to bring The Science of Sure to life. We are hiring for a Quality Engineer in our Design Quality team, onsite here in San Diego! As a key member of the Quality Engineering team, you will play an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. You will also support the company's quality system activities and design comply with the FDA's Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. Key Outcomes Work with product development teams to ensure appropriate design control measures are applied during the development and transfer of Hologic products. Provide Quality Engineering support for product design and development from feasibility through transfer into commercialization and post launch surveillance and change management activities. Support research and development teams with platform or systems reliability testing and characterization with both hardware and software. Serve as core team member on New Product Development projects to ensure compliance with design controls, as well as identify and address potential product issues in the design. Assess design changes from a systems perspective, identifying risks, delivering design mitigations, and evaluating the effectiveness of the risk control measures. Support design control and risk management activities, review/approve design control and risk management documentation ensuring compliance to established requirements. Provide guidance to core team members and key stakeholders on Quality Systems requirements and Design Controls. Participate in project teams to review and update clear and concise user requirements, product specs, plans, verification and validations studies, risk management file and other relevant design control deliverables. Support FMEAs and other risk assessment processes and documentation. Lead or support non-conformance or CAPA related initiatives with NCE and CAPA process. Support regulatory inspections and audits associated with design control documentation. Do you have what it takes? You are a good communicator, a team player, an "out of the box" thinker. You have strong influencing and negotiation skills. Experience with design, developing, and implementing Design Control Quality Systems SOPs, forms, protocols, report templates. Advanced working knowledge of, and experience with design control, design change management, quality control and documentation requirements. Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP) and quality system tools (e.g. electronic CAPA, complaint management systems) Additional qualifications and information Bachelor's degree in engineering or a life science discipline or equivalent Minimum of 2 - 5 years of experience, specific to design control/quality product design experience in a regulated environment, ideally in the IVD space. Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other applicable quality and regulatory standards. Extensive experience and understanding of design, development, verification, and validation processes. Strong knowledge of scientific principles and concepts. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role. From a benefits perspective, you will join our wide-ranging benefits policy including PTO, Employee Stock Purchase Plans, exciting Employee Wellness plans and many more. The annualized base salary range for this role is $78,300 - $122,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
12/04/2025
Full time
Here at Hologic it is our purpose to enable healthier lives everywhere, every day. We are driven by our passion to become the global champion for women's health. We achieve this by fulfilling our promise to bring The Science of Sure to life. We are hiring for a Quality Engineer in our Design Quality team, onsite here in San Diego! As a key member of the Quality Engineering team, you will play an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations. You will also support the company's quality system activities and design comply with the FDA's Quality System Regulations (QSRs), ISO 13485, and applicable state requirements. Key Outcomes Work with product development teams to ensure appropriate design control measures are applied during the development and transfer of Hologic products. Provide Quality Engineering support for product design and development from feasibility through transfer into commercialization and post launch surveillance and change management activities. Support research and development teams with platform or systems reliability testing and characterization with both hardware and software. Serve as core team member on New Product Development projects to ensure compliance with design controls, as well as identify and address potential product issues in the design. Assess design changes from a systems perspective, identifying risks, delivering design mitigations, and evaluating the effectiveness of the risk control measures. Support design control and risk management activities, review/approve design control and risk management documentation ensuring compliance to established requirements. Provide guidance to core team members and key stakeholders on Quality Systems requirements and Design Controls. Participate in project teams to review and update clear and concise user requirements, product specs, plans, verification and validations studies, risk management file and other relevant design control deliverables. Support FMEAs and other risk assessment processes and documentation. Lead or support non-conformance or CAPA related initiatives with NCE and CAPA process. Support regulatory inspections and audits associated with design control documentation. Do you have what it takes? You are a good communicator, a team player, an "out of the box" thinker. You have strong influencing and negotiation skills. Experience with design, developing, and implementing Design Control Quality Systems SOPs, forms, protocols, report templates. Advanced working knowledge of, and experience with design control, design change management, quality control and documentation requirements. Experience with electronic product life cycle (PLM), enterprise resource planning tools (ERP) and quality system tools (e.g. electronic CAPA, complaint management systems) Additional qualifications and information Bachelor's degree in engineering or a life science discipline or equivalent Minimum of 2 - 5 years of experience, specific to design control/quality product design experience in a regulated environment, ideally in the IVD space. Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other applicable quality and regulatory standards. Extensive experience and understanding of design, development, verification, and validation processes. Strong knowledge of scientific principles and concepts. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow and giving you the tools and knowledge you need to succeed in your role. From a benefits perspective, you will join our wide-ranging benefits policy including PTO, Employee Stock Purchase Plans, exciting Employee Wellness plans and many more. The annualized base salary range for this role is $78,300 - $122,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Here at Hologic, we are driven by our passion to become the global champion for women's health. As a leading innovator of women's health, we are empowering people to live healthier lives everywhere, every day. The Installation Project Manager plays a key role in fulfilling our passion by leading the charge to deliver on-time and successful installations of our life-changing devices. This role will drive the end-to-end capital implementation including project planning, capital product installations, capital upgrades, and room renovation while participating in initiatives resulting in a new streamlined model that enables installation consistency, improved performance, costs, and governance. This is a customer-facing role representing Hologic at the highest standard. This role is highly dynamic, requiring strong critical thinking skills with the ability to think on your feet, deliver results, and build strong relationships. Collaboration and clear communication are crucial. Essential Duties and Responsibilities Works with local sales and installation teams as the customer's operational point of contact throughout the pre-install and physical installation phase Drives high quality and on-time execution of capital shipments through consistent management of our capital orders Delivers a best-in-class installation project management experience by forming strong relationships with our customers and through reliable project planning Exhibits ownership and accountability for each step of their capital projects Collaborates with internal and external partners to ensure installation site readiness through technical and construction requirement reviews, site walk-throughs, call coordination, and anticipation of potential issues Adaptable to potential issues, changes in project scope, process updates, timelines, and resources Able to analyze options and offer alternative solutions while balancing the customer and business strategic goals. Consistently communicates project goals, updates, risks, and changes in a clear and timely manner to all project stakeholders. Validates customer requested ship and delivery dates with install team members. Fosters a positive and collaborative environment with teammates and customers. Qualifications: Ability to establish, schedule, track and communicate all activities related to the installation of digital mammography imaging products. This includes pre-installation planning and equipment layout, site readiness, equipment delivery, and coordination and communication of FE, Connectivity, and Applications activities. Must be detail oriented and very organized. Must be able to travel within assigned territory as needed to meet with customers, contractors, and Hologic service personnel. Minimum travel expectation is 30%. Technical aptitude and fundamental knowledge of mammography and digital mammography in particular desired. Strong interpersonal skills. Education: Associate Degree in a technical or project management discipline. Bachelor's degree preferred. Equivalent blend of education and experience may be considered. Experience: 2 to 5 years' experience in capital equipment site planning and installation coordination. Specialized Knowledge: Architecture as it applies to site planning in capital equipment installation environment. Basic knowledge of standard drafting methods and practices. Fundamental knowledge of electrical requirements and networking terminology. The annualized base salary range for this role is $81,100 to $126,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. Same Posting Description for Internal and External Candidates
12/04/2025
Full time
Here at Hologic, we are driven by our passion to become the global champion for women's health. As a leading innovator of women's health, we are empowering people to live healthier lives everywhere, every day. The Installation Project Manager plays a key role in fulfilling our passion by leading the charge to deliver on-time and successful installations of our life-changing devices. This role will drive the end-to-end capital implementation including project planning, capital product installations, capital upgrades, and room renovation while participating in initiatives resulting in a new streamlined model that enables installation consistency, improved performance, costs, and governance. This is a customer-facing role representing Hologic at the highest standard. This role is highly dynamic, requiring strong critical thinking skills with the ability to think on your feet, deliver results, and build strong relationships. Collaboration and clear communication are crucial. Essential Duties and Responsibilities Works with local sales and installation teams as the customer's operational point of contact throughout the pre-install and physical installation phase Drives high quality and on-time execution of capital shipments through consistent management of our capital orders Delivers a best-in-class installation project management experience by forming strong relationships with our customers and through reliable project planning Exhibits ownership and accountability for each step of their capital projects Collaborates with internal and external partners to ensure installation site readiness through technical and construction requirement reviews, site walk-throughs, call coordination, and anticipation of potential issues Adaptable to potential issues, changes in project scope, process updates, timelines, and resources Able to analyze options and offer alternative solutions while balancing the customer and business strategic goals. Consistently communicates project goals, updates, risks, and changes in a clear and timely manner to all project stakeholders. Validates customer requested ship and delivery dates with install team members. Fosters a positive and collaborative environment with teammates and customers. Qualifications: Ability to establish, schedule, track and communicate all activities related to the installation of digital mammography imaging products. This includes pre-installation planning and equipment layout, site readiness, equipment delivery, and coordination and communication of FE, Connectivity, and Applications activities. Must be detail oriented and very organized. Must be able to travel within assigned territory as needed to meet with customers, contractors, and Hologic service personnel. Minimum travel expectation is 30%. Technical aptitude and fundamental knowledge of mammography and digital mammography in particular desired. Strong interpersonal skills. Education: Associate Degree in a technical or project management discipline. Bachelor's degree preferred. Equivalent blend of education and experience may be considered. Experience: 2 to 5 years' experience in capital equipment site planning and installation coordination. Specialized Knowledge: Architecture as it applies to site planning in capital equipment installation environment. Basic knowledge of standard drafting methods and practices. Fundamental knowledge of electrical requirements and networking terminology. The annualized base salary range for this role is $81,100 to $126,800 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. Same Posting Description for Internal and External Candidates
Are you ready to take the lead in ensuring the safety, reliability, and compliance of life-changing medical devices? At Hologic, we are seeking a Lead Design Assurance Engineer to provide strategic and technical leadership in design controls, risk management, and quality systems across the product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs, and Manufacturing Engineering teams to embed quality and compliance principles into every stage of development and post-market activities. With your advanced technical expertise and leadership skills, you will drive continuous improvement, mentor engineers, and influence strategic initiatives to ensure Hologic's products meet the highest global standards for safety, effectiveness, and innovation. Knowledge: Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019 (Risk Management), and EU MDR (Regulation 2017/745). Advanced understanding of medical device standards, including usability, reliability, electrical safety, and software regulations. Thorough knowledge of design control processes, verification and validation planning, and requirements traceability. Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices. Proficiency in statistical methods, test method validation (TMV), root cause analysis (RCA), and design of experiments (DOE). Skills: Proven ability to lead cross-functional teams in implementing design controls and risk management across the product lifecycle. Expertise in developing testable, measurable specifications aligned with risk-based methodologies. Strong technical writing and communication skills for preparing and presenting complex regulatory and quality concepts to diverse audiences. Ability to assess complex design documentation and advocate for compliance effectively. Proficient in statistical tools like Minitab or JMP and requirements/risk management systems such as Agile, Windchill, or ETQ. Exceptional leadership and mentorship abilities to develop and guide engineers, fostering technical depth and a culture of quality excellence. Skilled in managing multiple priorities with independence, accountability, and sound professional judgment. Preferred certifications: Certified Quality Engineer (ASQ CQE) and/or Six Sigma Black Belt. Behaviors: Ownership-driven, taking responsibility for ensuring safety, compliance, and effectiveness in all product development and sustaining activities. Strategic thinker with a focus on innovation and continuous improvement in design assurance practices. Collaborative and relationship-oriented, building strong partnerships across R&D, Regulatory, Operations, and Quality teams. Proactive and detail-oriented, ensuring timely execution of critical tasks and deliverables. Committed to fostering a culture of quality and regulatory excellence, both within teams and across the organization. Flexible and adaptable, thriving in a fast-paced, regulated environment while managing competing priorities. Experience: Bachelor's degree in Engineering, Biomedical Engineering, or related technical field required; Master's or Ph.D. preferred. 10+ years of experience in Design Assurance, Quality Engineering, or related technical roles within the medical device industry with a Bachelor's degree in Engineering or Life Sciences. 8+ years with a Master's degree or 5+ years with a Ph.D. in Engineering, Biomedical Science, or a related discipline. Hands-on experience with design controls, risk management, verification/validation, and sustaining engineering for medical devices. Proven track record of leading audits, regulatory inspections, and remediation initiatives. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $119,300-$186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
12/04/2025
Full time
Are you ready to take the lead in ensuring the safety, reliability, and compliance of life-changing medical devices? At Hologic, we are seeking a Lead Design Assurance Engineer to provide strategic and technical leadership in design controls, risk management, and quality systems across the product lifecycle. As a subject matter expert, you will partner with R&D, Regulatory Affairs, and Manufacturing Engineering teams to embed quality and compliance principles into every stage of development and post-market activities. With your advanced technical expertise and leadership skills, you will drive continuous improvement, mentor engineers, and influence strategic initiatives to ensure Hologic's products meet the highest global standards for safety, effectiveness, and innovation. Knowledge: Deep expertise in FDA 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971:2019 (Risk Management), and EU MDR (Regulation 2017/745). Advanced understanding of medical device standards, including usability, reliability, electrical safety, and software regulations. Thorough knowledge of design control processes, verification and validation planning, and requirements traceability. Familiarity with Good Laboratory Practices and global regulatory requirements for medical devices. Proficiency in statistical methods, test method validation (TMV), root cause analysis (RCA), and design of experiments (DOE). Skills: Proven ability to lead cross-functional teams in implementing design controls and risk management across the product lifecycle. Expertise in developing testable, measurable specifications aligned with risk-based methodologies. Strong technical writing and communication skills for preparing and presenting complex regulatory and quality concepts to diverse audiences. Ability to assess complex design documentation and advocate for compliance effectively. Proficient in statistical tools like Minitab or JMP and requirements/risk management systems such as Agile, Windchill, or ETQ. Exceptional leadership and mentorship abilities to develop and guide engineers, fostering technical depth and a culture of quality excellence. Skilled in managing multiple priorities with independence, accountability, and sound professional judgment. Preferred certifications: Certified Quality Engineer (ASQ CQE) and/or Six Sigma Black Belt. Behaviors: Ownership-driven, taking responsibility for ensuring safety, compliance, and effectiveness in all product development and sustaining activities. Strategic thinker with a focus on innovation and continuous improvement in design assurance practices. Collaborative and relationship-oriented, building strong partnerships across R&D, Regulatory, Operations, and Quality teams. Proactive and detail-oriented, ensuring timely execution of critical tasks and deliverables. Committed to fostering a culture of quality and regulatory excellence, both within teams and across the organization. Flexible and adaptable, thriving in a fast-paced, regulated environment while managing competing priorities. Experience: Bachelor's degree in Engineering, Biomedical Engineering, or related technical field required; Master's or Ph.D. preferred. 10+ years of experience in Design Assurance, Quality Engineering, or related technical roles within the medical device industry with a Bachelor's degree in Engineering or Life Sciences. 8+ years with a Master's degree or 5+ years with a Ph.D. in Engineering, Biomedical Science, or a related discipline. Hands-on experience with design controls, risk management, verification/validation, and sustaining engineering for medical devices. Proven track record of leading audits, regulatory inspections, and remediation initiatives. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $119,300-$186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
Are you passionate about ensuring operational excellence within a Quality Management System? At Hologic, we are seeking a Document Control Analyst to optimize our Documentation Control System. In this role, you'll facilitate and manage all change order activities in Agile, ensuring smooth transitions from initiation to implementation. You'll also support continuous improvement initiatives, assist with product changes, and play a critical role in maintaining compliance with quality and regulatory standards. If you thrive in a detail-oriented environment, enjoy collaborating across teams, and are ready to take ownership of key documentation processes, we'd love for you to join our team! Knowledge: Strong understanding of change order systems, including Agile and Oracle PLM systems (preferred). Knowledge of documentation control processes within a Quality Management System (QMS). Familiarity with FDA Quality System Regulations and ISO 13485 standards is a plus. Basic understanding of material disposition and product-related change processes. Skills: Exceptional attention to detail and data entry accuracy. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Strong interpersonal and communication skills to train and collaborate with cross-functional teams. Ability to manage and track multiple change orders from initiation to implementation. Analytical skills with the ability to use independent judgment to solve problems and optimize processes. Experience with Key Process Indicators (KPIs) and publishing status reports. Behaviors: Highly organized with a proactive approach to managing documentation and change order processes. A continuous improvement mindset, actively seeking opportunities to streamline and optimize workflows. Collaborative and adaptable, with a focus on supporting team members and business needs. Accountability and ownership in ensuring compliance and quality standards are met. Customer-service oriented with a focus on training and educating others on best practices. Experience: 4-6 years of experience in documentation control and/or managing change orders, preferably within a regulated industry (e.g., medical devices). Proven ability to manage change orders across their lifecycle, including approvals and implementation. Experience supporting internal, external, or third-party audits to demonstrate compliance with quality standards. Hands-on experience in industries regulated by FDA or ISO 13485 is highly preferred. Familiarity with integrating new business, products, or NPI activities into existing systems. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $57,100-$85,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
12/02/2025
Full time
Are you passionate about ensuring operational excellence within a Quality Management System? At Hologic, we are seeking a Document Control Analyst to optimize our Documentation Control System. In this role, you'll facilitate and manage all change order activities in Agile, ensuring smooth transitions from initiation to implementation. You'll also support continuous improvement initiatives, assist with product changes, and play a critical role in maintaining compliance with quality and regulatory standards. If you thrive in a detail-oriented environment, enjoy collaborating across teams, and are ready to take ownership of key documentation processes, we'd love for you to join our team! Knowledge: Strong understanding of change order systems, including Agile and Oracle PLM systems (preferred). Knowledge of documentation control processes within a Quality Management System (QMS). Familiarity with FDA Quality System Regulations and ISO 13485 standards is a plus. Basic understanding of material disposition and product-related change processes. Skills: Exceptional attention to detail and data entry accuracy. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Strong interpersonal and communication skills to train and collaborate with cross-functional teams. Ability to manage and track multiple change orders from initiation to implementation. Analytical skills with the ability to use independent judgment to solve problems and optimize processes. Experience with Key Process Indicators (KPIs) and publishing status reports. Behaviors: Highly organized with a proactive approach to managing documentation and change order processes. A continuous improvement mindset, actively seeking opportunities to streamline and optimize workflows. Collaborative and adaptable, with a focus on supporting team members and business needs. Accountability and ownership in ensuring compliance and quality standards are met. Customer-service oriented with a focus on training and educating others on best practices. Experience: 4-6 years of experience in documentation control and/or managing change orders, preferably within a regulated industry (e.g., medical devices). Proven ability to manage change orders across their lifecycle, including approvals and implementation. Experience supporting internal, external, or third-party audits to demonstrate compliance with quality standards. Hands-on experience in industries regulated by FDA or ISO 13485 is highly preferred. Familiarity with integrating new business, products, or NPI activities into existing systems. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $57,100-$85,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand. Agency and Third-Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
