General Manager Quality

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.