Quality Engineer

  • Reference: LK45363-4
  • Job Type: Permanent
  • Location: Clare, Limerick, Tipperary
  • Category: Production

Title: Quality Engineer

Location: Mid West

Summary:

My client an American Multinational with Operations in Limerick is looking to hire a Quality Engineer to oversee quality input, review and release during new product development including supplier and part approval through to transfer to manufacturing processes.

Responsibilities:

  • Quality lead on vendor and part appraisal and approval processes.
  • Monitor and drive compliance within the development process and/or operations to GMP and the requirements of the QMS within assigned area.
  • Ensure that appropriate quality plans, test methods, test plans , validation and risk (FMEA) documentation, are all in place and being adhered to during product development.
  • Key driver in Customer complaints handing, failure investigations and CAPA implementation and verification.
  • Establish and monitor process quality performance to determine when improvement actions are appropriate.
  • Ensure full compliance with regulatory requirements.
  • Oversee product testing and release activities, including disposition of non-conforming material, the identification of scope, control of related NC material, root cause and appropriate CAPA actions and thorough documentation of same within schedule.

Requirements:

  • Degree in an engineering/ quality related discipline
  • Certified QE
  • Technical report writing
  • Process validations/FMEA’s and protocols
  • Statistical analysis
  • Structured Problem Solving techniques
  • Understanding of Lean Principles
  • Ability to drive projects to completion
  • Guided by the disciplines of due diligence and compliance in all aspects of work.
  • Working knowledge of EN ISO 13485 the MDD 93/42 EEC and principles of GMP and FDA QSR 21 CFR Part 820 required

 

To apply for this role please forward your CV to ben.forde@collinsmcnicholas.ie or for a confidential discussion please call Ben on 061 512 274.


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Ben Forde

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  • Ben Forde
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  • 061 512274
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