Process Quality Engineer

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 MESExperience in audit and presenting on electronic DHR on advantage.Knowledge of software validation and electronic records compliance (21 CFR Part 11).