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.

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 organization in the IVD space.

* IVD Regulatory Compliance: 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.

* End-to-End IVD Lifecycle Quality:
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 (ISO
14971), Interactions with laboratories (ISO 15189)

* Laboratory & Clinical Study Quality:
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.

* Supplier & Material Quality:
Conduct new vendor audits, qualification and monitoring, and overseeing the quality aspects of IVD development, validation and patient testing performed by third parties

* Post-Market Quality & Continuous Improvement:
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.

* Cross-Functional Collaboration:

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

About You

Basic Qualification

* 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.

* Advanced degree (MS/PhD) preferred

* Minimum 1 year in regulatory affairs or…