Quality System Engineer with strong working knowledge of ISO13485 and FDA QSR requirements required for critical role with medical devices multinational in Galway 


  • Level 8 Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification/experience in Quality Assurance
  • 3-5 years’ experience as a Quality Engineer within the Medical Devices or Pharmaceutical industry
  • Strong working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements
  • Passionate about Regulatory compliance
  • Experience with internal & external audits
  • Experience working with an Enterprise Quality Management Software system (such as SmartSolve)
  • Ability to work under pressure
  • Excellent communication and inter-personal skills
  • Proven ability to influence
  • Excellent attention to detail and report writing skills
  • Highly organized with strong ability to prioritize tasks and work on own initiative
  • Must already be eligible to work in Ireland (sponsorship not provided)

Key Responsibilities:

  • Actively stays current with external and internal quality system standards and requirements
  • Providing Quality Systems support for the Galway site
  • Support QMS integration activity across the Galway site
  • Coordinate and manage all external audits
  • Manage the site internal audit process
  • Manage the site internal CAPA process
  • Approvals as defined on Oracle
  • Identify deficiencies in quality systems and defines systematic corrective actions
  • Develop effective quality metrics and communicate the results to key stakeholders using reports, presentations, and dashboards
  • Ensure compliance and drive improvements in QS processes
  • Assist in the preparation and maintenance of records associated with the management review process
  • Participate in Quality Systems projects under the direction of the Quality Director as well as other duties as assigned
  • Monthly Manufacturing Training Report (provided to HR, accounting for all training data analysis)

Please contact Emer Smith to discuss in confidence

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