Medical Devices JobsQuality Engineer (West Galway)

  • GY50720
  • Permanent
  • Galway

Collins McNicholas

A leading medical device organisation on the West side of Galway is seeking a Quality Engineer to join their business on a permanent basis

Key Duties

  • Quality Assurance oversight of operational activities, production, and validations and Technical Services projects to ensure QA systems and Manufacturing/Engineering systems have an independent assessment in order to remove any potential conflict of interest between ownership and administration.
  • Writing and reviewing SOP’s, Visual Standards and Guidance Documentation
  • Ensuring process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes
  • The following while serving as the QA representative on validation and technical services projects
    • Providing QA review and approval of site process and equipment validation documentation such as protocols, deviations and final reports.
    • Providing QA support for change controls
    • Managing and coordinating QA support during the execution of the project
    • Serving as the QA liaison with all vested parties including QA/QC laboratories, IT, Manufacturing, and Engineering
  • Serve as the QA representative on Validation and Technical Services projects.
  • Serve as the Quality Assurance Review site process and equipment validation documentation representative and approver for protocols, deviations, and final reports
  • Managing and coordinating QA support of any Supplier Quality and Distribution Quality Issues and investigations
  • Management and oversight of Supplier Quality agreements
  • Supporting change control activities associated with processes and equipment validations.
  • Managing and coordinating QA support for new and existing process equipment validation implementations

Key Requirements

  • Minimum B.S. Engineering, statistics, or sciences degree from an accredited institution.
  • Five (5) years of relevant experience, working in areas such as process validations, technology transfer or quality engineering. 
  • Advanced user of Excel and Statistical programs such as Minitab.
  • Experience in a GMP regulated environment preferred.
  • Experience in an aseptic manufacturing environment preferred.
  • Ability to work take initiative with a pro-active strategic approach to challenges
  • Demonstrated ability to apply analytical methods to business issues
  • Attention to detail
  • Ability to develop relationships internally and externally to achieve goals
  • Broad understanding of Quality Engineering and a strong business acumen

*Benefits will be included for this position along with a salary in line with your experience. 

For more information, please contact Elaine Dolan for a confidential discussion.

elaine.dolan@collinsmcnicholas.ie

091 706 718

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