Quality Assurance and Compliance Manager

6 days ago


Swansea, City and County of Swansea, United Kingdom Kinetica Full time
Job Description

Quality Assurance and Compliance Manager

About the Company:

Kinetica is seeking an experienced Quality Assurance and Compliance Manager to oversee quality at our medical device company based in South Wales.

Responsibilities:

  • Manage the Quality Management System to ensure compliance with ISO 13485, EU MDR, UK MDR, and FDA requirements.
  • Lead a team of QA and QC staff to achieve quality objectives.
  • Provide quality support to manufacturing and collaborate with departmental heads on quality training.
  • Act as the company representative for quality and oversee QC processes.
  • Maintain key quality systems, including CAPA, complaints management, and sterilization.
  • Ensure quality is integrated into all departments and facilitate data analysis.
  • Lead internal and external audits, ensuring the site remains compliant with regulatory requirements.

Requirements:

  • Excellent knowledge of medical device quality systems.
  • Educated to degree level.
  • Substantial experience in a leadership or senior role within a quality department and team.


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