Global Quality Assurance Specialist
2 weeks ago
Job Summary
As a Global Quality Assurance Specialist at BSI, you will play a key role in providing 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 ISO 13485 certification based schemes globally within ISO 17021 and other applicable accreditation and regulator schemes.
- Support the rollout of policy decisions and processes for medical device QMS audits globally, provide technical support for ISO 13485 certification and CE schemes, and deliver certification decisions for ISO 13485 certifications.
- Participate in smaller improvement projects, host regulator or accrediting body audits, and 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.
Requirements
- Demonstrate 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).
- Display a good understanding of product and QMS certification concepts and principles, a comprehensive understanding of quality systems, philosophies, and principles, and an awareness of certification, accreditation, and notified body roles.
- Hold a minimum of two years of hands-on medical device manufacturing experience and two years quality management experience for medical devices.
BSI Excellence Behaviours
- Client-centric
- Agile
- Collaborative
BSI conducts face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.
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