Global Quality and Accreditation Technical Expert
6 days ago
With a strong focus on medical device quality management systems, BSI is seeking an experienced Technical Reviewer to join our team. As a key member of our Global Quality and Accreditation department, you will be responsible for providing technical expertise in certificate decision-making, competence verification, and monitoring.
About the RoleThis exciting opportunity offers the chance to work with a leading global organization in the field of conformity assessment. As a Technical Reviewer, you will play a crucial role in ensuring the high standards of quality and accreditation are maintained across our operations.
Responsibilities- Support the development and maintenance of technical expertise in key areas relating to certificate decision-making, competence verification, and monitoring;
- Contribute to ad-hoc improvement projects aimed at enhancing our quality management systems;
- Provide technical support for ISO 13485 certification-based schemes globally, including ISO 17021 and other applicable accreditation and regulator schemes;
- Assist in the roll-out of policy decisions and processes for medical device QMS audits globally;
- Support the investigation of customer appeals, report reviewing, and 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 in 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;
- Perform competence verifier activities to support the auditor qualification process, if appropriate.
We are looking for an experienced professional with a strong understanding of QMS requirements as applied to medical devices, including applicable regulations and standards. You should have a good understanding of product and QMS certification concepts and principles, as well as a comprehensive understanding of quality systems, philosophies, and principles.
Awareness of certification, accreditation, and notified body roles is essential, along with experience in coordinating or conducting audits of medical device manufacturers to ISO13485. A minimum of two years' hands-on medical device manufacturing experience and two years' quality management experience for medical devices are required.
In return for your skills and experience, we offer a competitive salary of £60,000 - £80,000 per annum, depending on location and qualifications, as well as excellent benefits and opportunities for career growth and development.
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