Quality Manager

Quality Manager – South Wales - Medical

About the Company:

We are looking for an experienced Quality professional 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 medical device quality.