Senior Quality Assurance Engineer

We are looking for a Senior Quality Assurance Consultant with a technical and quality management system standard relating to device design and development background to join one of the UK’s leading product design companies.


Responsibilities
•

  • Design Reviews to assess quality and compliance
  • • Review requirements for traceability and testability
  • • Lead product risk management activities according to ISO14971
  • • Plan verification programmes, including interpretation and implementation of relevant standards, and establishment of acceptance criteria
  • • Perform analysis and interpretation of test data
  • • Supporting creation of Technical Files / Design History Files
  • • Including review of client’s Technical File / DHF
  • • Perform gap analysis against quality system and regulatory requirements
  • • Creation of essential requirements checklists

Requirements:
•

  • A good degree in Engineering or related technical discipline
  • • Significant experience of risk management with regard to Medical Product development (according to ISO14971)
  • • Excellent understanding of medical device directive 93/42/EEC, ISO13485 and FDA QSR
  • • Experience of Design Verification
  • • Excellent communication skills
  • • Ability to review the work of others

Desirable:
•

  • Knowledge and experience of implementing IEC 60601 and IEC 62304
  • • Experience of liaising with the US FDA with regards to device submissions
  • • Experience of Design Validation
  • • Experience of design and development of, and regulatory submission for combination products / borderline products
  • • Experience of regulatory requirements regarding testing of pharmaceuticals
  • • Experience of manufacturing line qualification processes
  • • Experience of other applicable European directives including 98/

Job Details

  • Job Ref: 11748
  • Salary: £40000 - £60000
  • Consultant Name: Aksana Walford
  •   Cambridge
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