Location: Massachusetts (Onsite)

Overview:

Seeking a Quality Post Market Surveillance Specialist to support post-market activities for medical devices, ensuring compliance with regulatory requirements and maintaining product quality.

Required Experience:

• 5+ years of experience in post-market surveillance in the medical device industry
• Hands-on experience with complaint handling and investigations
• Strong knowledge of FDA regulations and 21 CFR Part 820
• Experience with CAPA , root cause analysis , and risk management
• Experience with MDR reporting

Key Responsibilities:

• Manage and investigate product complaints and ensure timely closure
• Perform trend analysis to identify quality issues
• Support CAPA and root cause investigations
• Ensure compliance with regulatory requirements for post-market activities
• Prepare and submit MDR reports
• Collaborate with cross-functional teams to drive quality improvements