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
- Bachelor'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 Out
- Work 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.
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