Our Client, a Medical Research company, is looking for a Staff Quality Engineer- Pharma and Diagnostics for their Marlborough MA/ Hybrid location.

 

Responsibilities:

• Develop, implement and maintain quality systems and processes in compliance with FDA CFR Part 820, ISO 13485, IVDR 2017/746, ISO 14971 and other regulations, as appropriate, for IVD products


• Conduct hazard analysis and risk assessments for IVD products according to ISO14971 throughout the IVD product lifecycle


• Lead internal and external audits, including preparation, execution, and follow-up to ensure adherence to quality and client standards and regulatory requirements


• Oversee corrective and preventive action (CAPA) processes, non-conformance investigations and deviations to resolve quality issues


• Collaborate with cross-functional product development teams to integrate quality requirements into product design, verificatio...