Quality Assurance Specialist

3 weeks ago


Great Abington, United Kingdom Cure Talent Full time

Cure Talent is a pioneering recruitment agency specialising in Medical Devices and Female Health Diagnostics.

This role offers flexible working arrangements between home and site, with an estimated salary of £60,000 - £80,000 per annum.

The Quality System Manager will play a pivotal role in implementing and driving the development & maintenance of their Quality Management System (QMS), achieving UKCA Marking and assisting with transitioning towards CE Marking and FDA approval.

To succeed in this role, we are seeking an experienced Medical Device Quality Assurance professional with proven experience in QMS implementation and management, expertise in working within smaller organisations and understanding the nuances of early-stage development processes.

Key Responsibilities:
  • Implement, manage, and continuously improve the Quality Management System
  • Oversee the UKCA marking process, ensuring readiness for audits and regulatory milestones
  • Develop and manage supplier selection and auditing processes
  • Support regulatory strategies, including preparation for CE Marking and future FDA submissions
  • Ensure compliance with relevant regulations and support post-market activities
Requirements:
  • Proven experience in senior QA or QARA roles within Medical Devices
  • Experience and knowledge of QMS implementation based on 13485 standards
  • Strong knowledge of UKCA and CE marking processes, with a good understanding of FDA regulations
  • Experience in supplier management and auditing
  • Knowledge and experience of IVDs and subsequent regulations are advantageous


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