Device - Senior Quality Engineer, Invitro Diagnostics

Sanofi•Cambridge, MA

1d•$133,500 - $192,833

About The Position

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.

Requirements

Bachelor's degree in Engineering, Biomedical Engineering, Biochemistry, Molecular Biology, Analytical Chemistry, or related scientific discipline, with 10+ years in quality management within IVD or closely related diagnostic fields.
Minimum 1 year in regulatory affairs or quality management systems for IVD medical devices is preferred
Strong leadership experience required
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
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 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
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)
Strong problem-solving methodologies and root cause analysis capabilities
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

Nice To Haves

Advanced degree (MS/PhD) preferred
Manufacturing operations experience
Drug-device combination products knowledge

Responsibilities

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.
System leadership across IVD design, evidence generation, labeling, and lifecycle management. Serve as primary Quality interface with FDA and EU Notified Bodies for IVD, ensuring inspection readiness within the device domain. Support regulatory submissions in the U.S. as well as EU IVDR including conformity assessments. Contribute to performance evaluation reports and technical files while ensuring strong linkage between analytical validation and labeling requirements. Ensure labeling and Instructions for Use (IFU) compliance with ISO 18113 and 21 CFR 809.10. Drive global regulatory harmonization, anticipate Notified Body expectations, and integrate compliance requirements into design processes from early development.
Provide quality leadership across assay design, development, verification, validation, and commercial manufacturing. Ensure traceability from user needs through design inputs, outputs, validation, and clinical evidence. Drive consistent application of design controls and DHF/Technical File management. Oversee analytical performance studies (sensitivity, specificity, precision, linearity, interference, reference intervals). Contribute to technical documentation/design dossier, performance evaluation (scientific validity, analytical performance, clinical performance), support clinical evidence /studies (when required), Post-Markey Surveillance, risk management (ISO14971), Interactions with laboratories (ISO 15189)
Establish quality frameworks for internal development laboratories and external partner labs/CROs ensuring compliance with CLIA, CAP, and ISO 15189. Lead quality oversight for IVD clinical performance studies including protocol review, site qualification, monitoring, and data quality. Ensure alignment with ISO 20916 and regulatory requirements.
Conduct new vendor audits, qualification and monitoring, and overseeing the 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 (PMPF) strategies. Drive continuous improvement through data-driven quality metrics.
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