Quality Projects Engineer required by market leading medical device multinational in Galway to drive continuous improvement within the Value Stream. Experience working in medical device manufacturing is critical.

Responsibilities:

  • Develop and implement Value Improvement Projects
  • Lead quality-related projects within the value stream e.g. where significant process changes are required that originates from a customer complaint
  • Support cost improvement projects and non re-occurring expense activities 
  • Provides Quality support for the transfer of new product into commercial Manufacturing
  • Provides additional support to the Operations team when a new product is introduced to the value stream where required until the product has reached steady state
  • Completion of targeted assessments for prevention reviews for new products introduced to the value stream
  • Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices
  • Supports validation activities within the value stream including MVP’s, MVR’s, TMV’s, OQ/PQ, PPQ and revalidation assessments
  • Supports the approval of supplier change notifications
  • Supports audits for the value stream from external regulatory agencies and customers and leads preparation activities in advance of such audits
  • Updates Quality procedures and specifications as required through the change plan process
  • Provides root cause analysis & problem-solving guidance

Requirements: 

  • Level 8 Degree in Quality / Science, Engineering or related
  • 3+ years supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry
  • CAPA experience
  • Strong problem-solving skills
  • Good working knowledge of validation processes
  • Strong leadership skills
  • Project management experience advantageous

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

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