Device - Senior Quality Engineer, Invitro Diagnostics

Job Title: Devie - Senior Quality Engineer, Invitro Diagnostics Location: Cambridge, MA About the Job The Senior Quality Engineer – IVD Devices is a senior subject matter expert responsible for ensuring the quality, safety, and regulatory compliance of IVD devices 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. Responsibilities Contribute to the design and implementation of a fit‑for‑purpose IVD QMS aligned with ISO 13485, EU IVDR, and MDSAP; establish phase‑appropriate processes spanning research, development, validation, and commercial lifecycle; harmonize QMS practices across global functions and develop lean, scalable processes. Provide system leadership across IVD design, evidence generation, labeling, and lifecycle management; serve as primary Quality interface with FDA and EU Notified Bodies; support regulatory submissions in the U.S. and EU IVDR, including conformity assessments and technical file contributions. Ensure labeling and IFU compliance with ISO 18113 and 21 CFR 809.10; drive global regulatory harmonization and integrate compliance requirements into design processes from early development. Lead quality across assay design, development, verification, validation, and commercial manufacturing; ensure traceability from user needs through design inputs, outputs, validation, and clinical evidence; oversee analytical performance studies and support clinical evidence/studies. Establish quality frameworks for internal development laboratories and external partner labs/CROs; lead quality oversight for IVD clinical performance studies including protocol review, site qualification, monitoring, and data quality. Conduct new vendor audits, qualification and monitoring, and oversee quality aspects of IVD development, validation, and patient testing performed by third parties. Establish and manage nonconformance, deviation, CAPA, complaint handling, and vigilance reporting systems; define and implement post‑market performance follow‑up strategies; drive continuous improvement through data‑driven quality metrics. Collaborate closely with IVD development teams, Regulatory Affairs, Clinical, and Laboratory Operations, balancing scientific understanding with quality rigor and business objectives to support IVD commercialization and lifecycle management. Qualifications Bachelor's degree in Engineering, Biomedical Engineering, Biochemistry, Molecular Biology, Analytical Chemistry, or related scientific discipline. 10+ years in quality management within IVD or closely related diagnostic fields. Advanced degree (MS/PhD) preferred. Minimum 1 year in regulatory affairs or quality management systems for IVD medical devices preferred. Strong leadership experience required. Hands‑on experience with assay development and validation, laboratory quality systems implementation and management, and clinical and performance study support. Direct experience with analyte specific reagents and companion diagnostics. Proven track record building or transforming QMS in a developing organization. Experience supporting IVDs from concept through commercialization. Manufacturing operations experience and drug‑device combination products knowledge preferred. Technical Skills 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. Strong expertise in ISO 18113 series, ISO 15189, and CLSI guidelines. 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. 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. Proficiency in risk management tools and methodologies (FMEA, FTA, risk‑benefit analysis). Experience with complaint handling, MDR/vigilance reporting, and post‑market surveillance systems. 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. Benefits Employees may be eligible to participate in company benefit programs, including high‑quality healthcare, prevention and wellness programs, and at least 14 weeks of gender‑neutral parental leave. Equal Opportunity Sanofi Inc. and its U.S. affiliates are Equal Opportunity and affirmative action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, citizenship, marital status, disability, veteran status or any other characteristic protected by law. #J-18808-Ljbffr Sanofi