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Quality Systems Director

2 months ago

Bedford, Bedford, United Kingdom Cure Talent Full time
Job Description

Cure Talent is delighted to partner with a global leader in medical diagnostics and IVD products. Due to continued growth, we have an exciting opportunity for an experienced Quality Systems Manager to join their highly motivated team.

Key Responsibilities:

  • Lead and manage the quality systems team to ensure the effectiveness of the Quality Management System (QMS).
  • Maintain compliance across the design, development, manufacture, and distribution of in-vitro diagnostic medical devices.
  • Ensure adherence to regulatory requirements, including In-Vitro Diagnostic Medical Device Regulation 2017/746.

Requirements:

  • Strong experience managing quality and compliance in a medical device environment.
  • Knowledge of compliance management throughout the full design control lifecycle under ISO 13485 and US FDA 21 CFR Part 820.
  • A track record of improving established Quality Management Systems.
  • Proven leadership and people management skills, with the ability to inspire and influence key stakeholders at all levels.