Quality Engineer – Design Assurance

Quality/Design Assurance Engineer – Galway 

The Role

CREGG are recruiting for a Quality/Design Assurance Engineer for our medical device client based in Galway. 

Job Responsibilities

• You 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 & 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 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.

Interested candidates should submit an updated CV.

Please call Gary on 086-1030418 to apply, alternatively send an up-to-date CV to [email protected]

****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****

INDTRAC