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View Cache (Job ID 13829626)
Employer Brightwater
Job Title Quality Engineer
Description

This is an amazing opportunity to work with a world leading Medical Device company in Cork. They are looking for an experienced Quality Engineer to be involved in Business Improvements, Compliance/Regulatory Reviews, NPI, Risk Mitigation as well as Product Quality and Qualification. On offer is a 12 month contract with an attractive hourly rate for this very desirable role.

Key Responsibilities:

  • Support quality improvement initiatives.
  • Conduct bench marking to develop more effective methods for improving quality.
  • Ensure all products and processes adhere to correct standards such as ISO 13485, etc.
  • Review audits and ensure CAPA's are adequate.
  • Support NPI as part of design transfer.
  • Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints.
  • Approve IQ, OQ, PQ, TMV or Software Validation.
  • Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
  • Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.
Experience and Education:

  • 5+ years experience in a regulated environment.
  • 3rd Level Degree in related field.
  • Six Sigma Certification.
  • Experience in performing DOE and leading FMEA.
  • A good understanding and working knowledge of FDA and ISO regulations.
For more information please submit your CV or contact Simon Lehane on 021-4221000 or at s.lehane@brightwater.ie

This job originally appeared on RecruitIreland.com
Location Cork
Date Added 8 days ago
Apply Link
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