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).