Senior Quality Engineer
Our client, a dynamic, innovative Irish-based Medical Device company developing a unique, next-generation product designed to significantly improve outcomes for millions of patients globally in the cardiac and chronic disease management sector, are currently seeking a highly motivated Senior Quality Engineer to be a central driver of Quality Management System (QMS) and key manufacturing activities. Reporting to Quality Systems Manager, this is a hands-on role requiring a mix of technical knowledge, practical application, and cross-functional leadership as the company transitions our innovative product through design, production, and regulatory milestones.
Key Responsibilities
* QMS Leadership: Drive the daily implementation and continuous improvement of the Quality Management System (QMS).
* Design Assurance: Collaborate with R&D to develop and review essential technical documentation, including test specifications, part specifications, and design specifications.
* Manufacturing Support: Provide essential QA support for regulated manufacturing, including equipment qualification, process validation, and change control.
* Compliance & Audit: Coordinate and manage critical quality processes, including the internal audit programme, Material Review Board, NC/CAPA reviews, and the complaint process.
* Regulatory & Supply Chain: Interpret relevant international standards (ISO 13485, FDA, MDR) to ensure compliance. Support the supply chain team with supplier development and manufacturing requirements.
* Project Support: Provide quality expertise for regulatory submissions and clinical investigations.
Essential Skills & Experience
* Education: Bachelor’s Degree in Engineering, Science, or a related field.
* Experience: Minimum of 5+ years' recent experience in a Medical Device Quality or Design Assurance role.
* Regulatory Expertise: Strong, recent experience interpreting and applying major regulations, including FDA regulations, ISO 13485, and European Medical Device Directives.
* Skills: Exceptional attention to detail, strong analytical and problem-solving abilities, and an aptitude for identifying and implementing process improvements.
* Team Player: Excellent communication and influencing skills with a proven ability to collaborate effectively across R&D, Manufacturing, and Supply Chain teams.
Desirable (Bonus) Experience
* A Master's degree in a related field.
* Direct experience with implantable medical devices or complex process development in a highly regulated environment.
For further information please contact James Cassidy or call in confidence
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