Quality Engineer IIJoin a global leader in cutting-edge medical technology where advanced engineering meets meaningful impact, and be part of world-class teams developing life-changing devices used in hospitals worldwide.Enjoy a collaborative, people-first culture that invests in your growth while you work in a state-of-the-art facility driving breakthrough solutions in minimally invasive healthcare. This is your chance to build your expertise with an organisation known for excellence, innovation, and purpose.This position is based in Galway.About Your New JobDemonstrate a commitment to patient safety and product quality by adhering to sound quality practices and maintaining an effective quality system.Understand and comply with all regulations governing quality systems.Independently make decisions related to product quality, including the disposition of non-conforming products.Participate in customer complaint investigations for areas under your control.Drive continuous improvements in product and process quality.Promote awareness of best industry practices and make informed decisions, consulting the Quality Engineering Manager or Site QA Director for critical quality decisions.Be fully conversant with validation techniques and associated regulatory requirements.Possess knowledge of Risk Management and BSEN 14971 requirements.Compile and analyze operational, test, and validation data to establish technical specifications and performance standards.Participate in new product/technology transfers to ensure compliance with all internal and regulatory requirements.Utilize Six Sigma, Statistical Analysis, and Lean principles to investigate and solve problems and improve quality.Provide technical guidance to Associate Quality Engineers, Technicians, and Inspection staff.Collaborate with suppliers, other engineering disciplines, and customers as needed.Be familiar with the internal auditing process.What Skills You NeedAn NFQ Level 8 Degree (240 Credits) or equivalent in an Engineering or Science-related discipline.A minimum of 3-4 years of experience working at the Engineering level, ideally within the Medical Device industry or another highly regulated environment.Familiar with Internal Audit Processes.Fully motivated to achieve and demonstrate best practices in line with department and site objectives.Experience in Extrusions & Mouldings is desirable.What's on OfferCompetitive Salary : Attractive compensation package.Career Development : Opportunities for training and career advancement.Supportive Work Environment : Collaborative and innovative work culture.