Sr. Quality Engineer - Post Market Surveillance

Senior Quality Engineer - Post Market Surveillance & Complaint Handling

Hybrid | Germantown, MD

Full-Time

About the Opportunity

We are proud to be partnering with an innovative medical technology company to identify a Senior Quality Engineer who will play a critical role in leading Post Market Surveillance (PMS) and complaint handling activities. This is a high-impact position within a regulated environment, ideal for professionals passionate about product safety, regulatory compliance, and continuous improvement.

Key Responsibilities

• Lead the intake, investigation, and closure of customer complaints, ensuring compliance with global regulatory standards.
• Own and execute Post Market Surveillance activities , including trend analysis, risk assessments, and reporting.
• Collaborate cross-functionally with Engineering, Regulatory, Clinical, Customer Support, and Manufacturing to ensure thorough and timely investigations.
• Interpret failure modes and root causes, linking findings to risk management documentation.
• Maintain and manage complaint databases, ensuring audit readiness and regulatory alignment. (Trending customer complaints via salesforce or master control is a plus)
• Support internal and external audits related to PMS and complaint handling.

Required Qualifications

Why This Role Stands Out