Senior Medical Device Quality Assurance Specialist

6 days ago


Gold Coast, Queensland, Australia BSI Full time

At BSI, we are seeking an experienced Senior Medical Device Quality Assurance Specialist to join our team. This role offers a salary of £45,000 - £60,000 per annum, depending on experience.

About the Role

This is a challenging and rewarding opportunity for a skilled professional to provide medical device quality management system ownership to medical device and QMS audit teams globally.

  • We are looking for someone with 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).
  • You will be responsible for developing and maintaining technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring.
  • Supporting in ad hoc improvement projects, providing support of the ISO 13485 certification and CE schemes, delivering certification decisions for ISO 13485 certifications, participating in smaller improvement projects, and supporting in hosting regulator or accrediting body audits.
About You

To be successful in this role, you will need to have a minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices.

You should also have experience of co-ordinating or conducting audits of medical device manufacturers to ISO13485, knowledge of product and QMS certification concepts and principles, and an awareness of certification, accreditation and notified body roles.

What We Offer

In return for your expertise and commitment, we offer a competitive salary, comprehensive benefits package, and opportunities for professional development.

We value our employees' contributions and strive to create a collaborative work environment where everyone feels supported and motivated.



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