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Quality Specialist

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22280

Our client a major multinational based in Galway are looking for a Quality Specialist on an initial 12 month contract.


Responsibilities:

  • Provide compliance oversight and guidance for design transfer activities, as assigned.
  • Maintain awareness of applicable quality standards that regulate our industry.
  • Maintain vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
  • Support and/or lead the review and approval of related design records.
  • Support and/or lead the development and update of associated Risk Management files.
  • Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
  • Support and/or lead product and process improvement activities from a quality perspective, ensuring supporting information/rationale for change including reasons and justifications is acceptable.
  • Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.
  • Support and lead the development and implementation compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.
  • Provide guidance on IVDR related requirements.

Requirements:

  • Bachelor's degree in a relevant discipline.
  • Minimum of 3 years of experience in a medical devices.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717