Medical Device Quality Assurance Specialist

2 weeks ago


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

This is an exciting opportunity to join our team as a Medical Device Auditor at The British Standards Institution (BSI). As a Medical Device Auditor, you will be responsible for delivering high-quality audit services to our clients in the medical device industry.

Key Responsibilities
  • Analyze quality systems and assess ISO 13485, CE Marking, and MDSAP schemes.
  • Attend training and follow procedures/processes/policies within BSI for client management, home-based office management, equipment use, and internal/external communication.
  • Qualify as a Client Manager and participate in additional training based on 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 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 seeking a focused, ethical, and ambitious professional who can deliver superior performance, lead by example, demonstrate passion for the business, and inspire others. You should have integrity, ensuring business is conducted in an ethical manner, and have a commercial focus, understanding customers' needs and adding value.

This role requires a minimum of 100% travel to and from clients, including land and air travel. You should have a minimum of four years of full-time hands-on work experience in the medical device field, with a minimum of two years in design, manufacturing, or testing. You should also have degree-level qualifications relevant to medical devices.

The salary for this position ranges from $90,100 to $123,860 annually, based on various factors, including competencies, experience, education, location, divisional budget, and internal peer compensation comparisons. 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 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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