Senior Post Market Quality Engineer

Job Summary

Experienced in post-market quality activities, the contract Senior Post Market Quality Engineer will investigate product complaints, support post-market surveillance, and participate in remediation projects for cardiovascular medical devices.

Key responsibilities

• Investigate product complaints and perform root cause analysis
• Support Post Market Surveillance (PMS) activities and product performance monitoring
• Participate in remediation projects and corrective action initiatives

Required qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field
• 6+ years of experience in the Medical Device industry
• Strong experience with Complaint Handling and Post Market Surveillance (PMS)
• Experience supporting Remediation projects
• Knowledge of FDA regulations, ISO 13485, CAPA, and risk management