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Sr. Quality Engineer - Post Market Surveillance

Sr. Quality Engineer - Post Market Surveillance

EPM ScientificGermantown, Maryland, United States
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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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