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, verification and validation activities according ...