Medical Device Quality Engineer

Job Summary

Supporting post-market quality activities for commercialized medical devices, the remote Product Quality Engineer will lead complaint investigations, perform Health Risk Assessments, and drive CAPA activities on a 6-month contract basis.

Key responsibilities

• Lead complaint investigations and root cause analysis
• Perform Health Risk Assessments (HRAs) and drive CAPA activities
• Analyze complaint trends and product performance while supporting FDA compliance and audits

Required qualifications

• Experience in Medical Device Quality Engineering
• Proficiency in complaint investigations and root cause analysis
• Knowledge of CAPA and post-market surveillance
• Experience in an FDA regulated environment
• Ability to collaborate across cross-functional engineering teams