Senior IVD Quality Engineer: Design Controls & Compliance

Sanofi; Cambridge (MA); Hybrid; USD 140,000 - 200,000; Full time

Job summary

Sanofi is seeking a Senior Quality Engineer for In Vitro Diagnostics in Cambridge, MA. The role leads quality strategy across the product lifecycle, aligning with ISO 13485, EU IVDR, and FDA requirements to ensure regulatory compliance and lifecycle success.

Responsibilities include driving design controls, risk management, analytical validation, and post‑market surveillance, while partnering with R&D, Regulatory, Manufacturing, and Clinical teams to deliver safe, effective diagnostic products.

Qualifications

• Bachelor’s degree in engineering or related field (biomedical/analytical chemistry, etc.).
• 10+ years in quality management within IVD or related diagnostic fields.
• Advanced degree (MS/PhD) preferred with strong leadership experience.

Responsibilities

• Design, implement, and maintain ISO 13485/IVDR-aligned QMS across the product lifecycle.
• Provide strategic quality leadership for regulatory submissions and post-market activities.
• Lead design controls, risk management (ISO 14971), and verification/validation of analytical performance.
• Manage laboratory quality frameworks and supplier quality programs.
• Drive continuous quality improvement and cross-functional collaboration with R&D, Regulatory, and Manufacturing.

Skills

Quality leadership

Regulatory knowledge

Education

MS/PhD preferred

Job description

Sanofi is seeking a Senior Quality Engineer for In Vitro Diagnostics in Cambridge, MA. The role leads quality strategy across the product lifecycle, aligning with ISO 13485, EU IVDR, and FDA requirements to ensure regulatory compliance and lifecycle success.

Responsibilities include driving design controls, risk management, analytical validation, and post‑market surveillance, while partnering with R&D, Regulatory, Manufacturing, and Clinical teams to deliver safe, effective diagnostic products.