Device - Senior Quality Engineer, Invitro Diagnostics
Listed on 2026-06-19
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
Devie - Senior Quality Engineer, Invitro Diagnostics
Location:
Cambridge, MA
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 are an R&D‑driven, AI‑powered biopharma company committed to improving peoples’ 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 worldwide.
Main Responsibilities- Contribute to the design and implementation of a fit‑for‑purpose IVD QMS aligned with ISO 13485, EU IVDR, and MDSAP, harmonizing practices across global functions.
- Lead IVD regulatory compliance activities across design, evidence generation, labeling, and lifecycle management, serving as the primary Quality interface with FDA and EU Notified Bodies.
- Provide quality leadership across assay design, development, verification, validation, and commercial manufacturing, ensuring traceability and consistent application of design controls.
- Establish quality frameworks for internal development laboratories and external partner labs/CROs, ensuring compliance with CLIA, CAP, and ISO 15189.
- Conduct new vendor audits, qualification, and monitoring for IVD development, validation, and patient testing performed by third parties.
- Establish and manage nonconformance, deviation, CAPA, complaint handling, and vigilance reporting systems, driving continuous improvement through data‑driven quality metrics.
- Collaborate closely with IVD development teams, Regulatory Affairs, Clinical, and Laboratory Operations to balance scientific understanding, quality rigor, and business objectives.
- 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 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.
- 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.
- Additional preferred experience: manufacturing operations, drug‑device combination products knowledge.
- 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 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…
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