Senior IVD Quality Engineer: Design, Compliance & Lifecycle

Sanofi; Cambridge (MA); On-site; USD 134,000 - 193,000; Full time

Job summary

Sanofi seeks a Senior Quality Engineer – In Vitro Diagnostics in Cambridge, MA, to oversee quality, safety and regulatory compliance across the product lifecycle. The role demands expertise in ISO 13485, EU IVDR, FDA 21 CFR Parts 809/812/820, ISO 15189, and risk management per ISO 14971, with collaboration across R&D, Regulatory, Manufacturing, and Clinical teams.

Lead design controls, analytical validation, performance evaluation, and post‑market activities while ensuring inspection readiness

Qualifications

• Bachelor’s degree in engineering, Biomedical Engineering, Biochemistry, Molecular Biology, Analytical Chemistry, or related field.
• 10+ years in quality management within IVD or diagnostic fields preferred.

Responsibilities

• IVD QMS design and implementation aligned with ISO 13485, EU IVDR, and MDSAP.
• Strategic quality leadership across development, regulatory strategy, and lifecycle management.
• Oversee design controls, analytical validation, and performance evaluation activities.
• Lead lab qualification, audits, and CRO/diagnostic partner quality oversight.
• Drive post-market quality and continuous improvement with CAPA and surveillance insights.
• Collaborate with cross-functional teams including R&D and Regulatory Affairs.

Skills

Quality management

Regulatory compliance

Design controls

Risk management

IVD quality systems

Education

Bachelor’s degree in engineering/biomedical science

Advanced degree (MS/PhD)

Job description

Sanofi seeks a Senior Quality Engineer – In Vitro Diagnostics in Cambridge, MA, to oversee quality, safety and regulatory compliance across the product lifecycle. The role demands expertise in ISO 13485, EU IVDR, FDA 21 CFR Parts 809/812/820, ISO 15189, and risk management per ISO 14971, with collaboration across R&D, Regulatory, Manufacturing, and Clinical teams.

Lead design controls, analytical validation, performance evaluation, and post‑market activities while ensuring inspection readiness