Medical Device Quality Specialist

1 week ago


Chaoyang Qu, China BSI Full time
Job Description:

As a Medical Device Quality Specialist at BSI, you will play a vital role in ensuring the quality and safety of medical devices globally. Your primary responsibility will be to provide quality management system ownership to medical device and QMS audit teams.

Key Responsibilities:
  • Develop and maintain technical expertise in key areas related to certificate decision-making, competence verification, and competence monitoring;
  • SUPPORT IN AD-HOC IMPROVEMENT PROJECTS;
  • Technical support for ISO 13485 certification-based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE;
Requirements & Accountabilities:
  • Support the rollout of policy decisions and processes for medical device QMS audits globally;
  • Provide support for the ISO 13485 certification and CE schemes, investigating customer appeals, report reviewing, and supporting activities during regulator audits;
  • Deliver certification decisions for ISO 13485 certifications as eligible, with a goal to being qualified across all non-CE ISO13485 schemes where resource allows;
  • Participate in smaller improvement projects ensuring appropriate adherence to procedures;
  • Support hosting regulator or accrediting body audits;
  • Provide advice and support to QMS auditors globally, technical specialists, scheme managers, sales, marketing, and other BSI colleagues on BSI QMS requirements for medical devices;
  • Competence verifier activities to support the auditor qualification process if appropriate;
What We Offer:

We are offering a competitive salary ranging from £55,000 - £65,000 depending on experience, plus a comprehensive benefits package including health insurance, pension scheme, and generous holiday allowance.

This is an excellent opportunity to work with a leading global organization in the field of conformity assessment and certification, contributing to the growth and success of our clients and stakeholders. If you are a motivated and experienced professional with a passion for quality and excellence, we encourage you to apply for this exciting role.



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