Medical Devices JobsSenior Projects Quality Engineer

  • GY50261
  • Permanent
  • Galway

Collins McNicholas

Global Medical Device organisation seeking a Senior Projects Quality Engineer with 5+ years experience and a Level 8 degree.

Key Duties

  • Demonstrates commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices.
  • Leads 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.
  • Leads cost improvement projects and NRE activities within the value stream from a quality perspective.
  • Leads quality support for the transfer of new product into device 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 TAP analysis for new products introduced to the value stream.
  • Leads validation activities within the value stream in conjunction with the validation group including MVP’s, MVR’s, TMV’s, OQ/PQ, PPQ and revalidation assessments.
  • Manages 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, specs as required through the change plan process.
  • Provides root cause analysis & problem-solving guidance and mentoring

Requirements 

  • Level 8 degree in Science, Engineering or related subject.
  • 5-7 years’ relevant supplier quality / quality operations experience in GMP manufacturing environment in Medical Device/Pharma industry
  • Significant project management experience
  • Very experienced in new product introductions.
  • Excellent knowledge of equipment qualifications, test method validation and process validation.
  • Ability to work as a team member and to provide mentorship to other team members.
  • Excellent communication and interpersonal skills and have demonstrated the ability to lead in a previous role.
  • Good organization and investigation skills are required.
  • A Black Belt qualification would be an advantage.
  • Excellent “hands-on” technical skills.
  • Excellent communication skills.

Package

  • Salary DOE
  • Bonus scheme
  • Healthcare scheme
  • Pension scheme

Please get in touch on elaine.dolan@collinsmcnicholas.ie for more information.

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