Senior IVD Quality Engineer — Lead Diagnostics Quality

Sanofi; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Sanofi in Cambridge, MA is seeking a Senior Quality Engineer for In Vitro Diagnostics. You will lead quality systems, regulatory strategy, and lifecycle activities across development to commercialization, ensuring compliance with ISO 13485, EU IVDR, and FDA regulations.

The role partners with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to drive design controls, analytical validation, and post‑market quality processes.

Qualifications

• Bachelor’s degree in engineering or a related field.
• 10+ years in quality management within IVD or closely related diagnostics.
• In‑depth knowledge of ISO 13485, EU IVDR (2017/746), FDA 21 CFR Part 820 (QSR), and 21 CFR Part 809 (IVD regulations).

Responsibilities

• IVD Quality Management System design and implementation aligned with ISO 13485, EU IVDR, and MDSAP.
• Strategic quality leadership across regulatory submissions and lifecycle management.
• Establish and maintain quality frameworks for internal/external labs and CROs.
• Lead supplier qualification, audits, and performance monitoring.
• Manage nonconformance, CAPA, deviation, and post‑market surveillance.

Skills

Quality leadership

Regulatory knowledge

Design controls

Analytical validation

Clinical performance evaluation

Post‑market quality

Cross‑functional collaboration

Education

Bachelor’s degree in engineering

MS/PhD in a related field

Job description

Sanofi in Cambridge, MA is seeking a Senior Quality Engineer for In Vitro Diagnostics. You will lead quality systems, regulatory strategy, and lifecycle activities across development to commercialization, ensuring compliance with ISO 13485, EU IVDR, and FDA regulations.

The role partners with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to drive design controls, analytical validation, and post‑market quality processes.