Medical Device QMS Auditor

3 weeks ago


Reston, Virginia, United States The British Standards Institution (BSI) Full time
About the Role

We are seeking a highly skilled Medical Device QMS Auditor to join our team at The British Standards Institution (BSI). As a Medical Device Auditor, you will be responsible for delivering audit services to assigned clients in accordance with all BSI, scheme, and regulatory requirements.

Key Responsibilities:
  • Analyze quality systems and assess ISO 13485, CE Marking, and MDSAP schemes.
  • Attend required training and follow all procedures, processes, and policies within BSI for client management, home-based office management, equipment usage, and internal and external communication.
  • Achieve qualification to Client Manager status following the Qualifying Review.
  • Participate in additional training based on future business needs.
  • Manage a portfolio of assigned clients, scheduling visits, planning assessments, making travel arrangements, conducting assessments, and reporting results.
  • Monitor client accounts to ensure records, PointGlobal information, visit cycles, invoicing, and other related matters are properly handled to maintain client satisfaction.
  • Act as a team member and perform other assignments as needed to meet assessment delivery business objectives.
About You

We are looking for a focused, ethical, and ambitious professional who can deliver superior performance, lead by example, demonstrate passion for the business, and inspire others. The ideal candidate will have a minimum of four years of hands-on work experience in medical device design, manufacturing, or testing, with a degree-level qualification relevant to medical devices.

The salary for this position ranges from $90,100 to $123,860 annually, and BSI offers a competitive salary, group-sponsored health and dental, short-term and long-term disability, a company-matched 401k plan, company-paid life insurance, 11 paid holidays, and 4 weeks of paid time off.

BSI is an Equal Opportunity Employer and is committed to diversity. We are conducting face-to-face interviews where possible and will accommodate virtual interviews if needed.



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