Responsibility

  • Responsible for review and acceptance procedure of protocols and reports into the company’s document control system.
  • Responsible for QA review of Specifications and Technical drawings required by the supply chain for manufacture of their new device.
  • Raising problem reports, Non-Conformity reports, Corrective Action and Preventative Actions to address product quality concerns and/or QMS concerns.
  • Lead problem resolution sessions i.e. “8D”, “5Y” to determine root cause(s) and to assess effectiveness of solutions.
Requirement
  • Educated to degree level, with a related Bachelor’s degree in an Engineering or Science discipline.
  • Prior experience of internal and external auditing, ideally within a medical devices environment.
  • Transferable IT skills including eQMS.
  • Desirable: Experience in medical device process verification and validation including: Injection Moulding, PCBA, Crimping, ESD, Packaging, Sterilisation, Material Characterisation, Control of Clean Rooms.