Senior Projects Quality Engineer

MEDICAL DEVICES, TECHNICAL & ENGINEERING, SCIENCE & PHARMACEUTICAL, MANUFACTURING & OPERATIONS
MEDICAL DEVICES, TECHNICAL & ENGINEERING, SCIENCE & PHARMACEUTICAL, MANUFACTURING & OPERATIONS
Galway
Permanent
8322
Galway
Permanent
8322
Overview:

Senior Projects Quality Engineer - Galway - Medical Device


Job Responsibilities

  • Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
  • Lead quality-related projects within the Device Manufacturing Value Stream e.g. where significant process changes are required that originates from a CAPA or a customer complaint.
  • Lead cost improvement projects and NRE activities within the value stream from a quality perspective.
  • Lead quality support for the transfer of new products into device manufacturing.
  • Provide additional support to the operations team when a new product is introduced to the value stream where required until the product has reached a steady state.
  • Completion of TAP analysis for new products introduced to the value stream.
  • Lead validation activities within the value stream in conjunction with the validation group including MVPs, MVR’s, TMV’s, OQ/PQ, PPQ, and revalidation assessments.
  • Manage the approval of supplier change notifications.
  • Support audits for the value stream from external regulatory agencies and customers and lead preparation activities in advance of such audits.
  •  Update quality procedures, specs as required through the change plan process.
  •  Provide root cause analysis & problem-solving guidance and mentoring

Qualifications & Requirements needed

  • Level 8 degree in Science, Engineering, or a related subject.
  • 5-7 years’ relevant supplier quality/quality operations experience in a GMP manufacturing environment in Significant project management experience.
  • Very experienced in new product introductions.
  • Excellent knowledge of equipment qualifications, test method validation, and process validation.
  • A Black Belt qualification would be an advantage.
  • Excellent “hands-on” technical skills.

Excellent package on offer such as Full Healthcare, Pension & Bonus


Please contact Elaine Dolan for more information on elaine.dolan@collinsmcnicholas.ie

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Elaine Dolan
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