About this Role
Senior Design Assurance - Quality Engineer (Hybrid/WFH)
We are currently recruiting for a Senior DA Quality Engineer to join our team in Co. Galway. This is an exciting opportunity to work with the latest medical device products and technologies in a hybrid role.
Your Responsibilities
* Support sustaining commercial projects from a Design Assurance perspective.
* Ensure products comply with global standards throughout their lifecycle.
* Assess patient risk for design changes.
* Provide QA technical direction/input to qualification and validation activities.
* Generate Design Verification protocols and participate in regulatory submissions.
* Interface with Regulatory Affairs to minimize questions from regulatory agencies.
* Maintain knowledge of regulatory compliance requirements.
* Generate and approve change requests.
* Lead investigation analysis and timely completion of same.
* Collaborate with engineering and manufacturing functions to ensure quality standards.
Your Skills and Qualifications
* Level 8 qualification in Engineering/Science or relevant discipline.
* 4+ years of relevant industry experience in Quality Engineering/Design Assurance/R&D.
* Industry knowledge and experience in Medical Device preferred but not essential.
About Us
Cregg Group is a world-leading medical device company based in Co. Galway. We offer great career progression opportunities and a dynamic work environment.