Principal Quality Process Engineer
Galway

Contract
Do you want to make an impact to the medical device industry? Then we are looking for you!
We are working with a leading medical device client in Galway, who are looking for a Principal Quality Process Engineer to join their team.
  • Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485 and FDA regulations.
  • Support digital transformation initiatives by integrating quality controls into automated and data-driven manufacturing processes.
  • Ensure compliance with applicable regulatory requirements (FDA, EU MDR, ISO standards)
  • Collaborate with cross-functional teams to embed quality assurance into digital workflows, MES (Manufacturing Execution Systems), and ERP systems.
  • Monitor and validate data integrity across digital platforms used in production and quality control.
  • Support implementation of predictive analytics and AI tools for quality monitoring and defect prevention.
  • Lead or support IQ/OQ/PQ activities for new digital equipment and software systems.
  • Review and approve validation protocols, technical documentation, and change controls.
  • Maintain accurate and timely documentation of quality activities, including CAPAs, SCARs, and non-conformances.
  • Prepare for and participate in internal and external audits (FDA, Notified Bodies).
  • Conduct periodic reviews and trending analysis of quality metrics and digital system performance.
  • Ensure audit readiness of digital systems and electronic records.
  • Train staff on digital quality tools, regulatory requirements, and QMS procedures.
  • Provide guidance on data governance, cybersecurity, and digital traceability in regulated environments.
  • Experience in management of routers/ Bill Of Materials (BOMs) and associated milestones in manufacturing paperwork/ translation to a digital platform an advantage.
  • Experience in DHR/DMR management/collation through use of electronic systems and MES
  • Experience in audit and presenting on electronic DHR on advantage.
  • Knowledge of software validation and electronic records compliance (21 CFR Part 11).