Sr. Quality Engineer - Post Market Surveillance (...

Senior Quality Engineer - Post Market Surveillance & Complaint Handling Hybrid | Germantown, MD Full-Time About the OpportunityWe 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 ResponsibilitiesLead 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 QualificationsBachelor's degree in Engineering, Life Sciences, or a related technical discipline. 4-6 years of experience in Post Market Surveillance and complaint handling within a medical device or diagnostics environment. Strong working knowledge of 21 CFR 820/803, ISO 13485/14971, EU MDR (2017/745), and MEDDEV Vigilance Guidance. Excellent technical writing and communication skills. Proficiency in Microsoft Office and complaint management systems. Ability to work independently and collaboratively in a fast-paced, cross-functional environment. Why This Role Stands OutWork with a mission-driven organization focused on improving patient outcomes. Hybrid flexibility with a collaborative and inclusive team culture. Opportunity to lead and shape quality processes in a growing company. Competitive compensation and benefits.

Created: 2025-10-08