Senior Quality Engineer

1 week ago

West Yorkshire, United Kingdom Kinetica UK Ltd Full time £70,000
Search our vacancies within the Life Science, MedTech and Healthcare sectors below.

Senior Quality Engineer – Site Based – Yorkshire - Medical

About the Company:

We are looking for several experienced Quality Engineers to join an expanding medical device company commutable based in central Yorkshire. You will join a close-knit quality team and interact regularly with the production department.

Responsibilities:

  • Providing quality engineering support to other areas within the business.
  • Assisting with design verification and validation.
  • Providing support to inspection teams.
  • Providing support to process validation (IQ, OQ, PQ).
  • Non- conformance investigations.
  • Post-market assessment.
  • Reviewing and approving design changes.
  • Ensuring that processes and procedures are compliant.
  • Assisting with standards reviews.
  • Ensuring documentation and production records are compliant.
  • Creation and approval of test protocols.
  • Creation and review of technical reports and documentation.
  • Lead cross function teams for improvement projects.
  • Assisting in the completion of the Validation Master Plan.
  • Auditing (internal and external).
  • Equipment maintenance and calibration.
  • Root cause analysis investigations.
  • NCRs
  • CAPA
  • Compliant investigation.

Requirements:

  • Educated to degree level in a relevant scientific or engineering discipline.
  • Significant experience working in a similar role within the medical device industry.
  • Experience with non-conformances, investigations, root cause analysis, risk analysis and CAPA.
  • A good understanding of 21CFR820, ISO13485 and ISO14971.
  • Excellent spoken and written English language skills.

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