Senior Quality Engineer In Vitro Diagnostics

Sanofi · Cambridge, MA, United States of America

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Company
Sanofi
Location
Cambridge, MA, United States of America
Employment type
Full-time
Posted
September 7, 2026

About this job

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 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…

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