Global Quality and Accreditation Specialist

2 weeks ago


Chaoyang Qu, China BSI Full time

At BSI, we are seeking a highly skilled Global Quality and Accreditation Specialist to join our team.

The role is to provide medical device quality management system ownership to medical device and QMS audit teams globally.

The responsibilities include:

  • Developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring;
  • Supporting in ad hoc improvement projects;
  • Technical support of the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes, such as MDSAP and CE.

The ideal candidate should have a good understanding of QMS requirements as applied to medical devices, including applicable regulations and standards (ISO 13485 and MDD, AIMD and/or IVDD, MDR/IVDR and MDSAP requirements in particular).

They should also have experience of co-ordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits).

A minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices is required.

Our Excellence Behaviours: Client-centric, Agile, Collaborative.



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