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Senior Quality Engineer In Vitro Diagnostics Employer Sanofi Location Cambridge, Massachusetts Start date Sep 10, 2026 View more categories View less categories Discipline Engineering , Quality Engineer , Quality , Quality Control Required Education Bachelors Degree Position Type Full time Hotbed Genetown Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job

Job Details Company Job Details Job Title :

Senior Quality Engineer, In Vitro Diagnostics Location:

Cambridge, MA About the Job The Senior Quality Engineer In Vitro Diagnostics is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVDs across the full product lifecyclefrom early development through commercialization and lifecycle management. Partnering with the Senior IVD Director, this role requires deep technical and regulatory expertise including

EU IVDR, FDA 21 CFR

Part 809/812/820, ISO 13485, ISO 18113, and

ISO 15189.

The incumbent serves as a strategic quality partner to cross-functional teams including R D, Regulatory Affairs, Manufacturing, Clinical, and Laboratory Operations, providing expert guidance on design controls, analytical validation, clinical performance evaluation, and post-market quality requirements. We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi:

Were an R D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.

Main Responsibilities IVD Quality Management System:

Contribute to the design and implementation of a fit-for-purpose IVD QMS aligned with

ISO 13485, EU

IVDR, and MDSAP. This includes working with key stakeholders to establish phase-appropriate processes spanning research, development, validation, and commercial lifecycle. Harmonize QMS practices across global functions and develops lean, scalable processes suitable for a growing organization in the IVD space.

IVD Regulatory Compliance:

Provide strategic quality leadership across IVD development, evidence generation, labeling, regulatory strategy, and lifecycle management, ensuring compliance with FDA and international regulatory requirements, including

EU IVDR, ISO

18113, and 21 CFR Part 809. Support global regulatory submissions and conformity assessment activities for diagnostic, biomarker, patient selection, and companion diagnostic programs, including

PMA, 510

(k), IDE, IND, NDA, and BLA submissions, as well as EU IVDR Technical Documentation reviews and Notified Body interactions. Review analytical validation, clinical performance, and assay data to support regulatory decision-making, including SR/NSR and IDE determinations. Ensure quality oversight of Technical Documentation, Performance Evaluation Reports, and GSPR compliance, maintaining traceability between intended use, risk management, performance evidence, labeling, and regulatory claims while supporting inspection readiness and successful regulatory outcomes.

End-to-End Lifecycle Quality:

Provide quality leadership across assay development, validation, design transfer, commercialization, and lifecycle management, ensuring compliance with design controls and maintaining traceability from intended use and user needs through verification, validation, risk management, clinical evidence, and labeling. Maintain Design History Files (DHF), Technical Documentation, and Technical Files while overseeing analytical validation and performance evaluation activities, including scientific validity, analytical performance, and clinical performance. Ensure risk management principles consistent with

ISO 14971

are integrated throughout the product lifecycle and provide quality oversight for clinical studies, post-market surveillance activities, and continuous monitoring of diagnostic product performance.

Laboratory and Clinical Study Quality:

Establish and maintain quality frameworks for internal and external laboratories, CROs, and diagnostic partners; lead laboratory qualification activities including assessments, audits, quality agreements, performance monitoring, and inspection readiness; ensure compliance with applicable standards and regulations; and provide quality oversight of biomarker, patient-selection, companion diagnostic, and laboratory-developed assays, including review of validation packages for fitness-for-purpose.

Supplier & Partner Quality:

Conduct supplier qualification, audits, and monitoring, and oversee the quality aspects of IVD development, validation, patient testing, and diagnostic activities performed by third parties.

Post-Market Quality & Continuous Improvement:

Establish and manage nonconformance, deviation, CAPA, complaint handling, and vigilance reporting systems. Define and implement post-market performance follow-up (PMPF) strategies. Drive continuous improvement through data-driven quality metrics.

Cross-Functional Collaboration:

Work closely with IVD development teams, Regulatory Affairs, Clinical, and Laboratory Operations. Balance scientific understanding with quality rigor and business objectives to support IVD commercialization and lifecycle management About You Basic Qualifications Bachelors degree in engineering, Biomedical Engineering, Biochemistry, Molecular Biology, Analytical Chemistry, or any field 10+ years in quality management within IVD or closely related diagnostic fields. Preferred Qualifications Advanced degree (MS/PhD) Strong leadership experience Hands-on experience with assay development and validation Laboratory quality systems implementation and management Clinical and performance study support Direct experience with diagnostic, biomarker, and patient selection assays and companion diagnostic programs Proven track record building or transforming QMS in developing organization Experience supporting IVDs from concept through commercialization Manufacturing operations experience Drug-device combination products knowledge

Quality Management Systems & Regulatory Compliance:

In-depth knowledge of

ISO 13485

2016, EU IVDR (2017/746), FDA 21 CFR Part 820 (QSR), and 21 CFR Part 809 (IVD regulations) Proven track record implementing and certifying QMS systems across multiple sites Working knowledge of MDSAP (Medical Device Single Audit Program) requirements Comprehensive GxP knowledge and experience in implementation and maintenance of compliant systems

IVD-Specific Standards & Requirements:

Strong expertise in

ISO 18113

series, ISO 15189, and CLSI guideline Knowledge of

IEC 62304

(software lifecycle) and

IEC 62366-1

(usability engineering) for IVD products with software/SaMD components Understanding of

ISO 14971

risk management principles applied to IVD devices Experience with technical documentation, performance evaluation, and post-market obligations under

EU IVDR IVD

Development & Validation:

Demonstrated experience with design controls and DHF/Technical File management for IVD devices Hands-on experience with analytical performance studies (precision, accuracy, linearity, interference, reference interval studies) Experience with process validation (IQ/OQ/PQ), analytical method validation, and design transfer for IVD manufacturing Knowledge of assay development lifecycle and validation requirements

Risk Management & Problem Solving:

Proficiency in risk management tools and methodologies (FMEA, FTA, risk-benefit analysis) Strong problem-solving methodologies and root cause analysis capabilities Experience with complaint handling, MDR/vigilance reporting, and post-market surveillance systems

Emerging Technologies:

Familiarity with SaMD quality considerations including algorithm validation, cybersecurity, and AI/ML-based IVD products Ability to navigate complex global regulatory environments and drive organizational alignment Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply. Power industry-leading performance by leveraging digital, data, and AI-driven innovation at speed and scale Transform lives worldwide by delivering life-changing treatments anywhere, anytime. Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. Company Pursue Progress. Discover Extraordinary. Science has been our calling from the beginning. Sanofi's heritage of turning the impossible into the possible stretches back to the 19th century — a rich history of healthcare innovation built by diverse companies united by one shared purpose. More than 150 years later, that spirit lives in everything we do and every person we serve — from the patients who take our medicines, to the healthcare professionals who trust us, to the 83,000+ employees and communities around the world who make it all possible. And today, we're writing the next chapter of that legacy. We are an R D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Better is out there. Better medications, better outcomes, better science. And it all starts with people like you — from different backgrounds, in different locations, doing different roles — united by a single mission: we chase the miracles of science to improve people's lives. Take the most important step in your career and help us change the lives of patients, families, and communities for the better. Company info Location Cambridge Massachusetts United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert Similar jobs Engineer Operational Excellence #4893 Durham, NC Specialist, Quality Control, Equipment Norwood, Massachusetts Engineer Thousand Oaks, California