Our client, a growing medical device organisation based in Galway are seeking an experienced Product Quality and Quality Assurance Engineer. This role will report directly to the VP of Operations as well as working in conjunction with the Quality Team. You will be responsible ongoing management & development of product manufacturing & quality programs with the sub-contract manufacturing partners for new and existing products, ensuring that its internal quality system for process and product controls is in compliance with ISO 13485 and FDA Quality System Regulations.
Duties and responsibilities of the Product Quality and Quality Assurance Engineer will include:
- Implementation and oversight of Supplier Quality Management plans / agreements, including review, supplier audits, issue resolution and scorecard-based supplier performance management.
- Development and maintenance of Quality Management programs aimed at optimising process and product quality with sub-contractors and other suppliers, including supplier visits as needed.
- Provide technical & quality support during transfer of products and associated technology from design to sub-contractors including PQP development / process qualification & validation and production support including qualification.
- Support customer complaints process with specific responsibility for product related issues including investigation, root cause analysis, corrective action and customer feedback.
You will have skills and experience in the following:
- Degree in Engineering/Science or related discipline
- 3+ years relevant experience in medical device
- Working experience of managing external suppliers and experience working with a certified Quality Management System
For more information on this opportunity, talk to Laura Gallagher in confidence, email or call her direct line 00 353 91782113.