Senior Supplier Quality Engineer – Medical Devices
About the Role
A global leader in medical devices and diagnostics is expanding its supplier quality team at its state-of-the-art facility in North Dublin. This new role has been created as part of a strategic supply chain transfer, offering an exciting opportunity to shape supplier quality processes at the site.
As a Senior Supplier Quality Engineer, you will be responsible for onboarding and managing suppliers, ensuring compliance with ISO 13485 and FDA regulations while driving continuous improvement initiatives. You will work cross-functionally with Manufacturing, R&D, Quality Assurance, and Suppliers to ensure a smooth transition of the supply chain while maintaining the highest quality standards. This is an excellent opportunity to make a lasting impact on a high-performing team and contribute to a world-class supply chain.
Key Responsibilities
- Lead supplier onboarding and qualification to ensure compliance with ISO 13485 and regulatory standards.
- Oversee supplier audits, capability assessments, and risk management processes to drive quality improvements.
- Manage business transfers between suppliers, ensuring seamless transitions while maintaining compliance and quality.
- Collaborate with suppliers on First Article Inspections, CAPAs, and Root Cause Investigations.
- Develop and implement best-in-class supplier quality processes in a low-volume, high-complexity manufacturing environment.
- Conduct supplier performance reviews, analyse key quality metrics, and report findings to internal stakeholders.
- Travel to supplier sites on an ad hoc basis to conduct audits, inspections, and process evaluations.
Requirements
- Bachelor’s degree in Quality, Engineering, Science, or a related discipline.
- 8+ years of experience in a highly regulated industry, preferably in medical devices.
- Expertise in ISO 13485, FDA regulations, risk management, and supplier quality assurance.
- Strong background in auditing and supplier onboarding processes.
- Experience with business transfers between suppliers (highly advantageous).
- Hands-on experience with CAPAs, First Article Reports, and supplier development.
- Proficiency in statistical analysis tools (Minitab), SAP, and product lifecycle management systems.
- Excellent leadership, communication, and problem-solving skills with a proactive mindset.
- Willingness to travel to supplier sites as required.
Why Apply?
- Join a global leader in medical devices, working on an innovative supply chain transfer project.
- Play a key role in establishing and developing supplier quality processes at a new strategic site.
- Work in a cutting-edge, high-tech environment with significant career growth opportunities.
Take the Next Step in Your Career
This is an exciting opportunity to make a significant impact in a world-class medical device organisation. If you have the expertise, leadership, and drive to excel in supplier quality, we want to hear from you. Apply now and be part of this dynamic expansion in North Dublin!
For more information, call Kerry Rickard on 086 044 3981.
