Quality Assurance Role
We are seeking a Senior Quality Engineer to play a critical part in ensuring the quality and reliability of our medical devices. The ideal candidate will have a strong background in quality assurance, design validation, and risk management.
Main Responsibilities:
* Support commercial projects from a Design Assurance perspective, guaranteeing that products comply with global standards throughout their lifecycle.
* Assess patient risk appropriately for design changes and provide QA technical direction/input to qualification and validation activities.
* Generate Design Verification protocols and contribute to the compilation of design verification and shelf life data for regulatory submissions.
* Collaborate with Regulatory Affairs to ensure clear information presentation, minimizing Regulatory Agency questions.
* Establish strong working relationships across functions and partners within a complex technical environment.
Key qualifications include:
* Design Assurance and Medical Device Quality Engineering expertise.
* Experience with risk management, change management, and product/process/materials changing.
* Strong knowledge of FDA, ANSI/AAMI/ISO requirements.
* Collaboration and communication skills, with ability to work cross-functionally.
This contract position is based in Galway, Ireland. If you have the required skills and experience, please apply with your resume and cover letter.