Senior Quality Engineer In Vitro Diagnostics

Job Title:

Senior Quality Engineer, In Vitro Diagnostics

Location:

Cambridge, MA

The Senior Quality Engineer – In Vitro Diagnostics is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVD’s across the full product lifecycle, from 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  Manufacturing & Supply, you’ll help reimagine how life‑changing treatments reach people everywhere, faster.

About Sanofi:

We’re an R&D‑driven, AI‑powered biopharma company committed to improving people’s 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.

• 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…