Senior IVD Quality Engineer – End-to-End Diagnostics

BioSpace; Cambridge (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

Sanofi is seeking a Senior Quality Engineer in In Vitro Diagnostics to lead quality across the product lifecycle, ensuring regulatory compliance and robust design controls. The role collaborates with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to support development through commercialization.

Candidate should have 10+ years in IVD quality, with deep ISO 13485, EU IVDR, and FDA knowledge, and prefer an advanced degree.

Qualifications

• Bachelor's degree in engineering or related field required.
• 10+ years of quality management experience in IVD or related diagnostics.
• Preferred: MS/PhD in a related field.
• Strong knowledge of ISO 13485, EU IVDR, FDA 21 CFR Part 820/809.

Responsibilities

• Lead design controls and lifecycle quality across development to commercialization.
• Provide strategic quality leadership for regulatory submissions and post‑market activities.
• Establish and maintain DHF/Technical File, risk management per ISO 14971.
• Oversight of lab and clinical study quality, supplier and partner quality.

Skills

Quality leadership

Regulatory knowledge

Cross-functional collaboration

Design controls

Education

Bachelor's degree in engineering or related field

MS/PhD in a related field (Preferred)

Job description

Sanofi is seeking a Senior Quality Engineer in In Vitro Diagnostics to lead quality across the product lifecycle, ensuring regulatory compliance and robust design controls. The role collaborates with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to support development through commercialization.

Candidate should have 10+ years in IVD quality, with deep ISO 13485, EU IVDR, and FDA knowledge, and prefer an advanced degree.