Quality Projects Engineer required to join a market leading medical device organisation based in Galway. You should have prior experience working in a highly regulated medical device or pharmaceutical environment.

Responsibilities:

  • Demonstrates commitment to the Quality Policy through the daily execution of sound quality practices.
  • Leads quality related projects within the Device Manufacturing Value Stream.
  • Supports CIP and NRE activities within the value stream.
  • Provides quality support for the transfer of new product into device manufacturing.
  • Provides additional support to the operations team when a new product is introduced.
  • Completion of TAP analysis for new products.
  • Supports validation activities within the value stream.
  • Supports the approval of supplier change notifications.
  • Supports audits for the value stream from external regulatory agencies.
  • Updates quality procedures, specs as required.
  • Provides root cause analysis & problem-solving guidance.

Requirements: 

  • BSc. in Science, Engineering or related.
  • 5+ years supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry.
  • Project management experience.
  • Good working knowledge of validation processes.
  • Ability to work as a team member.
  • Demonstrated the ability to lead in a previous role.
  • Good organization and investigation skills are required.
  • A Green Belt qualification  advantageous.
  • Excellent “hands-on” technical skills.
  • Must be authorised to work in Ireland.

Please contact Emer Smith to discuss in confidence
00353578638188       
emer@emtechrecruitment.ie

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