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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Senior Quality Engineer


Reference:SMC359 Location: Galway
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, Quality Engineer

We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Collaborate with the Project teams to facilitate the successful execution of the Design Services process and Commercialization of new products
  • Experience with NCRs / CAPAs / SCAR
  • Provide expertise in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory Compliance and Submissions
  • Lead and Support Design Services engineering activities (including but not limited to)
  • New product introductions
  • Development and approval of new product documentation.
  • Qualification of new suppliers/ requalification of existing suppliers
  • dFMEA , Risk management activities
  • Test method development/validation activities
  • Product / process validation protocol development and execution (IQ, OQ, PQ)
  • Represent QA as part of the Material Review Board
  • Perform Internal and Supplier Audits

Education & Experience
  • A degree in manufacturing engineering, quality engineering, life science or related field and experience within the Medical Device Industry or other highly regulated industry.
  • Proven record of handling multiple tasks simultaneously and ability to manage project timelines


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.