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Project Quality Engineer

Project Quality Engineer

Project Quality Engineer - urgently required for a High volume Medical Devices manufacturing comapny in the Galway area.

 

Role:

  • 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 e.g. capacity expansions and new product variations within the value stream from a quality perspective.
  • 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.
     

What your background should look like:

 

Qualifications

 

  • Level 8 degree in Science, Engineering or related subject. 
  • 3+ years relevant Supplier Quality / Quality Operations experience in good manufacturing practice manufacturing environment in Medical Device/Pharma industry.
  • Project management experience.


Key Requirements

 

  • Green Belt qualification would be an advantage.
  • Good working knowledge of validation processes.
  • Ability to work as a team member.
  • Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
  • Good organization and investigation skills are required.
  • Excellent “hands-on” technical skills.

Excellent communication skills.