Quality Engineer

15 Oct 2019

Quality Engineer required -Med Device Manufacturing MNC

Our Global Med Device Manufacturing client, require a Quality Engineer to join their workforce and play a pivotal role in delivering first class solutions to the world's most prominent pharmaceutical and healthcare companies.

Job Purpose:

The Quality Engineer will create and deliver quality plans, programs and procedures, utilising quality control statistics and focusing on the Six Sigma approach. Ensure that performance and product quality adhere to company & regulatory requirements. Review and report on quality inconsistencies across assembly and process. Probe problems and advise on modification and reactive action and adjustments where appropriate (Re: Frequent & Non-frequent discrepancies).

Key requirements:

  • Manage the and oversee work carried out by the Quality Department
  • Deliver expert technical guidance during the New Product Introduction process in ensuring all FDA, QSR, & MDD standards are adhered to
  • Lead & manage the necessary validation protocols, & amendments of the quality management system in ensuring compliance across applicable FDA directives/requirements etc.
  • Provide expert assistance to the Quality Management System auditing function
  • Cross functional networking to drive quality initiatives across the company as a whole
  • GMP & Health & Safety compliant at all times
  • Adherence & Support of Company regulations at all times

Education and experience:

  • Degree in Engineering, Science or related discipline.
  • 6 years + experience in a Quality Engineering role with experience within a manufacturing within GMP environment.
  • In depth knowledge of Quality Management Standards.
  • Experience utilising CAPA tools
  • Exceptional People Management and Coaching skills
  • Performance and results orientated
  • Solid background across Validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA's

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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Orfhlaith O'Donoghue's picture
Recruitment Consultant | Engineering | Quality & Validation 
Limerick 016324650 | oodonoghue@morganmckinley.ie