Medical Device Assurance Specialist

1 day ago


Oxford, Oxfordshire, United Kingdom Skills Alliance Full time
Job Overview: A world-leading medical technology company is seeking a motivated Design Assurance Engineer to join the team. As part of its global expansion, this role will support quality assurance by ensuring regulatory compliant design life cycle documentation is produced. This position involves confirming adherence to procedures and global standards, participating in design verification testing, and collaborating with R&D, Post-Market Engineering, and Quality teams.

The successful candidate will be involved in the quality assurance of the full development lifecycle of new and existing products. The role requires flexible working hours and will be based in Oxford, UK.

Responsibilities:
  • Ensure design quality through the full lifecycle process in accordance with standards and procedures of a class III medical device.
  • Complete relevant documentation and verification test reports for devices and systems, according to documentation procedures.
  • Assist in design and risk review of new and existing medical devices.
  • Support and conduct risk assessments and failure mode and effects analysis (FMEA) to identify and mitigate potential issues.

Requirements:
  • Bachelor's degree within an engineering discipline or equivalent
  • 3+ years of experience within quality in the medical device industry
  • Experience with Class III or II medical device background
  • Expert knowledge cGMP, 21 CFR 820, ISO13485, 14971. IEC 60601, 62304
  • Experience working in a full product development lifecycle environment, participating in design reviews, and ensuring design requirements are met.

Estimated Salary Range: £50,000 - £70,000 per annum, depending on experience.

This is a fantastic opportunity to work in a dynamic and innovative company dedicated to improving patient outcomes.

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