The RoleCREGG are recruiting for a Quality/Design Assurance Engineer for our medical device client based in Galway.Job ResponsibilitiesYou will act as an extended team member on a PDP Project, representing the Design Assurance function and reporting indirectly to the quality lead on the project.You will be responsible for preparing test method validations, design verification and shelf‑life protocols/reports.You will stay updated on industry best practices concerning product design.You will keep expert knowledge of regulatory compliance requirements for product design, development, transfer, and commercialisation activities.You will collaborate with various departments both internally and externally to build strong partnerships.You will provide Quality input into new product development, NPI, process improvements, and change control.Education & ExperienceWe are seeking a qualified individual with a minimum Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science) and a minimum of 2 years of relevant experience.The candidate should be an established and productive individual contributor who works independently with general supervision on larger, moderately complex projects and assignments.The candidate should be a dynamic team player and leader who can work effectively and proactively on cross‑functional teams.The candidate should have competent experience in medical device product design.Experience with CAPA, non‑conformance, DHF, medical device design, regulations, EU MDR and change controls desirable.Excellent communication skills and the ability to influence are critical for this role.Fluency in English, both written and spoken, is required.NotesThe client cannot assist with visa sponsorship; candidates must have the correct visa to live and work in Ireland.
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