Our client, a global medical device and diagnostic organisation, are seeking an experienced Staff Quality Engineer to join the team at their state-of-the-art manufacturing facility in South Dublin.
The Staff Quality Engineer will be working closely with R&D and global Quality teams on an exciting and innovative project, providing design control expertise and a creative problem-solving approach to support new product development and product maintenance.
Duties and responsibilities of the Staff Quality Engineer will include:
- Assisting/conducting Failure Investigations and problem-solving sessions for non-conforming products
- Consistent application of technical principles, theories, concepts, and quality sciences / tools
- Reviewing and having Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
- Ensuring quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
- May provide guidance and work direction to other team members
- Designing and performing development, working independently within defined parameters with minimal supervision required
You will have skills and experience in the following:
- Bachelor's degree in Engineering, Science or similar
- Ideally 10+ years of relevant Quality Engineering experience in the medical devices industry sector
- Thorough understanding of industry regulations: QSR/cGMP, ISO QM standards including ISO13485, ISO149741, IEC60601, IEC62304 and EU MDD/MDR
- Experience with electromechanical device and device software standards and requirements is essential
- Must be a dynamic problem solver, able to anticipate potential problems and create solutions
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.