Senior IVD Quality Engineer: Regulatory & Lifecycle Lead

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

Job summary

Sanofi in Cambridge, MA is seeking a Senior Quality Engineer for In Vitro Diagnostics to drive quality across the product lifecycle, ensuring compliance with ISO 13485, EU IVDR, FDA 21 CFR Part 820, and related standards.

You will partner with R&D, Regulatory Affairs, Manufacturing and Clinical teams to implement design controls, analytical validation, lifecycle management, and post-market quality systems, with a focus on risk management and inspection readiness.

Qualifications

• Bachelor’s degree in engineering or related field.
• 10+ years in quality management within IVD or closely related diagnostic fields.
• Advanced degree preferred.

Responsibilities

• Design and implement IVD QMS aligned with ISO 13485/EU IVDR/MDSAP.
• Provide strategic quality leadership across regulatory submissions and lifecycle management.
• Oversee analytical validation, performance evaluation, risk management, and labeling.
• Lead laboratory qualification and supplier quality activities.
• Drive post-market quality improvements and CAPA processes.

Skills

Quality management

Regulatory knowledge

Cross-functional collaboration

Leadership

Analytical thinking

Education

Bachelor’s degree in engineering or related field

Advanced degree (MS/PhD)

Tools

MDSAP

Job description

Sanofi in Cambridge, MA is seeking a Senior Quality Engineer for In Vitro Diagnostics to drive quality across the product lifecycle, ensuring compliance with ISO 13485, EU IVDR, FDA 21 CFR Part 820, and related standards.

You will partner with R&D, Regulatory Affairs, Manufacturing and Clinical teams to implement design controls, analytical validation, lifecycle management, and post-market quality systems, with a focus on risk management and inspection readiness.