Sanofi
Healthcare
Device-SeniorQualityEngineer,InvitroDiagnostics
Neural analysis suggests this role is
optimal for Senior candidates.
“Device - Senior Quality Engineer, Invitro Diagnostics at Sanofi. Skills: IVD Quality, Regulatory Compliance, QMS, Design Controls. Contribute to IVD QMS design and implementation. Establish phase-appropriate processes”
Industry & Context.
Root cause analysis; Troubleshooting
What They're Looking For.
Must Have
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, Hands-on experience with assay development and validation, Laboratory quality systems implementation and management, Clinical and performance study support, Direct experience with Analyte Specific Reagents and Companion Diagnostics, Proven track record building or transforming QMS in developing organization, Experience supporting IVDs from concept through commercialization
Nice to Have
Advanced degree (MS/PhD) preferred, Minimum 1 year in regulatory affairs or quality management systems for IVD medical devices, leadership experience required, Manufacturing operations experience, Drug-device combination products knowledge
What You'll Do.
Contribute to IVD QMS design and implementation
Establish phase-appropriate processes
Harmonize QMS practices globally
Provide system leadership across IVD design
Serve as primary Quality interface with FDA and
Ensure inspection readiness
Support regulatory submissions
Contribute to performance evaluation reports
Ensure linkage between analytical validation and labeling
Ensure labeling and IFU compliance
Drive global regulatory harmonization
Integrate compliance requirements into design processes
Provide quality leadership across assay lifecycle
Ensure traceability from user needs
Drive consistent application of design controls
Oversee analytical performance studies
Contribute to technical documentation/design dossier
Support clinical evidence/studies
Manage Post-Market Surveillance
Manage risk management
Interact with laboratories
Establish quality frameworks for laboratories
Lead quality oversight for IVD clinical performance studies
Ensure alignment with ISO 20916
Conduct new vendor audits
Oversee quality aspects of third-party development
Establish and manage nonconformance systems
Establish and manage deviation systems
Establish and manage CAPA systems
Establish and manage complaint handling systems
Establish and manage vigilance reporting systems
Define and implement PMPF strategies
Drive continuous improvement through metrics
Work closely with IVD development teams
Balance scientific understanding with quality rigor
Support IVD commercialization and lifecycle management
How You'll Work.
Team & Collaboration
Cross-functional teams; R&D; Regulatory Affairs; Manufacturing; Clinical; Laboratory Operations
Full Job Description
**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. 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. **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. **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 orga
Applying for this Device - Senior Quality Engineer, Invitro Diagnostics role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Sanofi?
Real rants from real employees. Read before you apply.