General Manager Quality

2 months ago


Swansea, United Kingdom Kinetica Full time

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.



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