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Device - Senior Quality Engineer, Invitro Diagnostics at sanofi us - ApplyBlast

Device - Senior Quality Engineer, Invitro Diagnostics

sanofi us

4 months ago

Cambridge, MA

Onsite

Full Time

Senior

0 applicants

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About this role

A Senior Quality Engineer for IVD Devices at Sanofi ensures the quality, safety, and regulatory compliance of in vitro diagnostic products across their entire lifecycle. As a strategic subject matter expert, the role involves leading QMS implementation, managing regulatory interfaces with the FDA and EU Notified Bodies, and overseeing clinical and laboratory study quality. This position collaborates with cross-functional teams to drive continuous improvement and risk management in a global IVD environment.

Responsibilities

Lead design and implementation of fit-for-purpose IVD quality management systems
Serve as primary quality interface with FDA and EU Notified Bodies for inspections
Oversee end-to-end IVD lifecycle quality including assay development and validation
Establish quality frameworks for internal and external laboratory operations
Drive continuous improvement through data-driven quality metrics and post-market surveillance

Skills

Qualifications

BS in Engineering, Biomedical Engineering, Biochemistry, Molecular Biology, or Analytical ChemistryMS or PhD preferredMedical Device Quality Engineer certification preferred