General Manager Quality
3 weeks ago
Quality Manager – South Wales - Medical
About the Company:
We are looking for an experienced Quality Manager to oversee quality at a medical device company based in South Wales. As well as being responsible for quality on site you will manage an established team of QA and QC staff.
Responsibilities:
- Ensuring compliance with ISO 13485, EU MDR, UK MDR and FDA requirements.
- Managing the Quality Management System.
- Managing the quality department.
- Providing quality support to manufacturing.
- Leading and managing quality projects.
- Acting as the company representative for quality.
- Overseeing QC.
- Maintaining key quality systems including CAPA, complaints management and sterilization.
- Data analysis.
- Ensuring that quality is seen as an essential part of the work for all departments.
- Acting as the site lead for external audits.
- Leading internal audits.
- Collaborating with departmental heads regarding quality training.
- Preparing and delivering management presentations for the quality department.
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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