Our cleint 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 compamny transition 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 [email protected] or call in confidence 086 0204322
