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Global Quality and Accreditation Specialist
4 weeks ago
We are seeking a highly skilled Global Quality and Accreditation Specialist to join our team at BSI.
Job SummaryThis is an exciting opportunity for a technical expert to provide medical device quality management system ownership to medical device and QMS audit teams globally.
Main Responsibilities- To develop and maintain technical expertise in key areas relating to certificate decision making, competence verification and competence monitoring;
- To support ad-hoc improvement projects;
- To provide 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 will 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 addition, they should possess experience of coordinating or conducting audits of medical device manufacturers to ISO13485 (e.g. supplier or internal audits) and a comprehensive understanding of quality systems, philosophies and principles.
Minimum two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices are required.
Key Skills and Qualifications- Good understanding of QMS requirements as applied to medical devices;
- Experience of coordinating or conducting audits of medical device manufacturers;
- Comprehensive understanding of quality systems, philosophies and principles;
- Awareness of certification, accreditation and notified body roles;
- Minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices.
We offer a competitive salary of £50,000 - £70,000 per annum, depending on experience, plus excellent benefits package.
About BSIBSI is a global organization that provides business improvement tools, services, and standards.
We help organizations drive performance, improve operations, and manage risk.
What We Offer- A competitive salary;
- An excellent benefits package;
- Ongoing training and development opportunities;
- A collaborative and supportive work environment;
- The opportunity to work with a leading global organization.
