Quality Engineering Manager Job In Galway

Quality Engineering Manager sought for global medical device company in Galway, leading Quality Engineering function to deliver best-in-practice Quality Engineering, driving performance and compliance. Our client, a global medical device company, is seeking a Quality Engineering Manager to lead and develop the Quality Engineering function. This is a fully remote position with occasional travel to their Galway office. **Key Responsibilities:** • Lead and develop the Quality Engineering function to deliver best-in-practice Quality Engineering, driving performance and compliance. • Ensure manufactured products meet requirements of end-users, Regulatory Authorities, and the company. • Develop and maintain performance measurements and report on these during management review meetings and quality performance meetings. • Liaise with Regulatory bodies to ensure Quality Systems compliance by all departments and personnel. • Manage ongoing Quality issues and present technical data to stakeholders to ensure prompt decisions on related issues. **Requirements:** • Degree in Engineering, Technology, or Science. • Demonstrated audit/inspection experience. • Understanding of EN ISO 13485 and FDA regulations. • Formal Audit Training. • CQM / CQE courses preferred. • 10+ years' experience in a regulated medical device company. • Knowledge of QMS Requirements and Regulations. • Knowledge of the EU MDR, ISO 13485, and FDA QSR. • Experience in quality audits by Notified Bodies and FDA. • Relevant experience and knowledge with the Risk Management process according to ISO 14971. • Previous experience with biocompatibility testing (ISO 10993 requirements). • Previous experience and knowledge with the ETO sterilization process.