Quality Systems Manager

2 months ago

Bedford, United Kingdom Cure Talent Full time

Cure Talent is delighted to partner with a global leader in medical diagnostics and IVD products. Their reputation for delivering accurate, user-friendly solutions that empower individuals to take control of their health is second to none.


Due to continued growth, we have an exciting opportunity for an experienced Quality Systems Manager to join their highly motivated team. The successful candidate will be responsible for leading and managing the quality systems team, ensuring the effectiveness of the Quality Management System (QMS), and maintaining compliance across the design, development, manufacture, and distribution of in-vitro diagnostic medical devices.


Compliance is required with the following standards:


  • ISO 13485
  • Council Directive 98/79/EC
  • In-Vitro Diagnostic Medical Device Regulation 2017/746
  • UK CE Mark
  • US FDA 21 CFR Part 820


We are looking for a Quality Systems Manager with the following skills and experience:


  • 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.
  • Lead Auditor qualification or relevant experience (preferred but not essential).
  • 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 (this is key)


If you want to be part of an organisation that’s passionate about people and innovation in healthcare, this is a fantastic opportunity to lead a talented team and make a positive impact. Click "Apply Now" to learn more and register your interest.

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