Quality Manager – South Wales - Medical
About the Company:
We are seeking an experienced Quality Manager to oversee quality at a medical device company in South Wales. The successful candidate will be responsible for managing an established team of QA and QC staff.
Key Responsibilities:
* Ensure compliance with ISO 13485, EU MDR, UK MDR and FDA regulations.
* Manage the Quality Management System.
* Oversee the quality department.
* Provide quality support to manufacturing.
* Lead and manage quality projects.
* Act as the company representative for quality matters.
* Oversee QC activities.
* Maintain key quality systems including CAPA, complaints management, and sterilization.
* Analyze data to inform quality decisions.
* Educate all departments on the importance of quality in their work.
* Act as site lead for external audits.
* Conduct internal audits.
* Collaborate with departmental heads to develop quality training programs.
* Present management reports on quality department performance.
Requirements:
* Excellent knowledge of medical device quality systems, including ISO13485, 21 CFR Part 807, EU MDR, and UK MDR.
* Degree-level education.
* Substantial experience in a leadership or senior role within a quality department and team.