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Global Quality and Accreditation Specialist
2 months ago
**About the Role**
BSI is seeking a highly skilled Global Quality and Accreditation Specialist to join our team. As a key member of our Global Quality and Accreditation team, you will play a critical role in providing medical device quality management system ownership to medical device and QMS audit teams globally.
**Key Responsibilities**
- Develop and maintain technical expertise in key areas relating to certificate decision making, competence verification, and competence monitoring.
- Support ad hoc improvement projects and provide technical support for the ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes.
- Support the roll out of policy decisions and processes for medical device QMS audits globally.
- Provide support for the ISO 13485 certification and CE schemes, including 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 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.
- Competence verifier activities to support the auditor qualification process, if appropriate.
**Requirements**
- 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).
- A good understanding of product and QMS certification concepts and principles.
- A comprehensive understanding of quality systems, philosophies, and principles.
- An awareness of certification, accreditation, and notified body roles.
- Experience of coordinating or conducting audits of medical device manufacturers to ISO13485 (e.g., supplier or internal audits).
- Minimum of two years of hands-on medical device manufacturing experience and two years of quality management experience for medical devices.
**Our Excellence Behaviours**
Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.
