Quality Assurance Specialist

3 weeks ago


Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time
About the Role

We are seeking a Quality and Compliance Manager to join our Clinical Product Team at the HealthHero Group. The successful candidate will have extensive knowledge and experience in quality management and governance of medical devices within an ISO 13485 accredited healthcare organisation.

As a key member of our team, you will be responsible for ensuring that our medical devices meet the highest standards of quality and compliance. This includes managing the quality and compliance of our products throughout their entire lifecycle, including the maintenance of relevant standards and certifications.

You will work closely with our product, technical, and client services teams to ensure effective engagement and communication with external stakeholders. Your role will also involve supporting and enabling our Clinical Product family and market expansion plans.

Key responsibilities include:

  • Providing support and guidance on all aspects of Product Quality, Compliance & Governance.
  • Acting as a Business Partner for the relevant Department/Business Area, with specific focus on Medical Device regulations.
  • Managing the quality and compliance of the whole product lifecycle, including compliance and maintenance of relevant standards and certifications.

Requirements:

  • Knowledge and experience of quality management and the governance of medical devices within an ISO 13485 accredited healthcare organisation.
  • Desirable – have experience of software as a medical device including MDR submissions.

Benefits:

  • Company Pension scheme.
  • Access to HealthHero healthcare services, including Private 24/7 GP service and Employee Assistance Programme.
  • 25 days holiday + 8 days bank holiday and an extra day off for your birthday.
  • Electric Car scheme.
  • Cycle to work scheme.

Estimated salary: £65,000 - £85,000 per annum, based on location and experience.



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