Medical Device Compliance Officer

3 days ago


Oxford, Oxfordshire, United Kingdom Skills Alliance Full time

**About the Opportunity:**

We are looking for a Medical Device Compliance Officer to join our team at Skills Alliance.

This role is responsible for developing, establishing and maintaining quality engineering and inspection programs, policies, processes, procedures, and controls enhancing the performance and quality of products and the company capability to demonstrate conformance to established standards and agency regulations.

Responsibilities:

  • Assist with non-conformance and real-time data management portions of the quality System
  • Maintain effective quality metrics and define and execute activities to resolve decreases in performance
  • Be a champion of Quality, Six Sigma, Lean and disciplined problem solving

Requirements:

  • Bachelor's degree within an engineering discipline or equivalent
  • Minimum 3 years' experience working within quality at a medical device manufacture
  • Experience with Class II or III devices
  • Expert knowledge cGMP, 21 CFR 820, ISO13485, 14971
  • Estimated Salary: £60,000 - £80,000 per annum


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