Design Assurance Quality Engineer

CREGG are recruiting for an experienced Quality Engineer for our world leading Galway based medical device manufacturing client. Candidates with NPI or Design Assurance encouraged to apply. To hear more please submit CV to or call Rachel on . This role is only open to candidates with full working rights to work full time in Ireland.

Job Responsibilities

• You will work in the Coronary Therapies Department, representing the Design Assurance function and reporting indirectly to the quality lead on the project.
• 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 & Experience

• We 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 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.