Job Title
Quality Manager – South Wales - Medical Device Specialist
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About the Role
We are seeking an experienced Quality Manager to oversee quality at a medical device company based in South Wales.
The successful candidate will be responsible for managing an established team of QA and QC staff, ensuring compliance with regulatory requirements and maintaining key quality systems.
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Key Responsibilities
* Ensure compliance with ISO 13485, EU MDR, UK MDR, and FDA requirements.
* Manage the Quality Management System (QMS) and lead quality projects.
* Provide quality support to manufacturing and collaborate with departmental heads regarding quality training.
* Maintain key quality systems, including CAPA, complaints management, and sterilization.
* Act as the site lead for external audits and lead internal audits.
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Requirements
* Excellent knowledge of medical device quality systems, including ISO13485, 21 CFR Part 807, EU MDR, and UK MDR.
* Educated to degree level.
* Substantial experience in a leadership or senior role within a quality department and team.
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Salary Range: £60,000 - £80,000 per annum
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This is a challenging and rewarding opportunity for a skilled Quality Manager to join our organization in South Wales. If you have the necessary expertise and experience, we encourage you to apply.