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Quality Assurance Manager

2 months ago

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

About Kinetica:

We are a leading medical device company based in South Wales, dedicated to delivering high-quality products that meet the highest standards of safety and efficacy.

Job Summary:

We are seeking an experienced Quality Assurance Manager to oversee quality at our site, ensuring compliance with regulatory requirements and managing a team of QA and QC staff.

Key Responsibilities:

  • Ensure compliance with ISO 13485, EU MDR, UK MDR, and FDA requirements.
  • Manage the Quality Management System, including CAPA, complaints management, and sterilization.
  • Provide quality support to manufacturing and lead quality projects.
  • Act as the company representative for quality and oversee QC.
  • Maintain key quality systems and ensure data analysis is accurate.
  • Ensure quality is integrated into all departments and act as the site lead for external audits.
  • Lead internal audits and collaborate with departmental heads on quality training.
  • Prepare and deliver 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 managing a quality department and team.