Quality manager - Swansea
SRG are currently recruiting for a quality manager to join a small but well established medical device company in the Swansea area. They are looking for someone to join them on a permanent basis on a competitive salary.
You will be developing and managing the company's Quality Management System (QMS) in compliance with the requirements of ISO13485. You will be promoting the best quality practice in all areas of the company and developing individual members of the quality department. Furthermore, you will be developing the company-wide structures to facilitate the continued growth within the global market.
Responsibilities include but not limited to:
- Day to day support of manufacturing to provide a timely and effective resolution of quality related issues.
- Manage quality related improvement projects and provide quality support and expertise for wider improvement projects
- Responsible for Quality Control (Goods Receipt and Final Product Release)
- Management of key Quality Systems including- Change control- CAPA- Supplier Approval- Sterilisation
- - Environmental Control
- - Non-Conformance
- - Complaints
- - Document and Data Control
- Analysis of all information received through the monitoring of information received from customer complaints, non-conformance reports, audit reports and CAPAs.
- To facilitate the continued growth of the company within the constraints of ISO13485 and 21 CFR Part 807, EU MDR and UK MDR.
- Good, all-round knowledge of medical device quality systems with direct experience of ISO13485:2016, 21 CFR Part 807, EU MDR and UK MDR.
- Graduate qualification and or at least 5 years direct experience within a high-level quality function.
- Experience of managing a quality team.
To find out more, please apply or email Jessica.email@example.com
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