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Senior Quality Engineer

50415
  • Leeds
  • Permanent

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.
  • Risk management.
  • 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 communication skills.
  • Excellent spoken and written English language skills.
  • Ability to work autonomously.
  • Strong project management skills.
  • Good attention to details.

 

 

Claire Collinson Client Director Regulatory, Quality & R&D Recruitment

Apply for this role

  • info@kinetica.co.uk
  • +44 (0)113 261 71 81
  • Kinetica (UK) Ltd, Floor 13, Whitehall Waterfront, 2 Riverside Way, Leeds, LS1 4EH, UK