(08/11/2024) Quality Assurance Manager

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.