Job Description
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.