Senior Quality Assurance Manager

7 days ago

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

Job Summary:

We are seeking an experienced Quality Manager to oversee quality at Kinetica, a medical device company. The successful candidate will be responsible for managing the quality department, ensuring compliance with regulatory requirements, and providing quality support to manufacturing.

Key Responsibilities:

  • Manage the Quality Management System, ensuring it is effective and compliant with regulatory requirements.
  • Lead and manage a team of QA and QC staff, providing guidance and support to ensure quality is maintained.
  • Provide quality support to manufacturing, ensuring products meet regulatory requirements.
  • Act as the company representative for quality, ensuring Kinetica's quality systems are effective and compliant.
  • Oversee QC, ensuring all quality-related activities are completed efficiently and effectively.
  • Maintain key quality systems, including CAPA, complaints management, and sterilization.
  • Ensure data analysis is conducted to identify trends and areas for improvement.
  • Collaborate with departmental heads to ensure quality training is provided to all staff.
  • Prepare and deliver management presentations for the quality department, ensuring key performance indicators are met.
  • Ensure excellent knowledge of medical device quality systems, including ISO13485, 21 CFR Part 807, EU MDR, and UK MDR.
  • Substantial experience managing a quality department and team is essential.

Requirements:

  • Excellent knowledge of medical device quality systems.
  • Substantial experience managing a quality department and team.

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