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.
Job Description
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.
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
To be considered for this role, you must have:
* 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?
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.