Excellent opportunity for a Supplier Quality Engineer to join an innovative Medical Devices company based in Galway. The Supplier Quality Engineer will perform supplier quality activities for medical device components, finished goods, and services, ensuring compliance with FDA, EU MDR, and the Quality System. This will also include resolving supplier-related quality issues, managing ASL qualification, supplier selection, material qualification, and conducting supplier audits.
Overview of your responsibilities (full job description available on request):
- Experienced in plastic injection molding and assembly processes.
- Apply supplier quality tools and methods (SPC, Minitab, capability, IQ/OQ/PQ) to monitor performance.
- Maintain ASL compliance by keeping agreements, certifications, and oversight activities current.
- Support and lead supplier selection, qualification, and capability assessments.
- Drive 8D corrective actions for supplier-related quality issues, including root cause, CAPA, and effectiveness checks.
- Review nonconformances and complaints to develop action plans.
- Monitor supplier performance, provide feedback, and lead improvement initiatives.
- Conduct supplier audits and manage findings through closure using 8D.
- Collaborate cross-functionally to ensure supplier compliance with specifications, QMS, and regulatory requirements.
- Partner with suppliers to ensure on-time delivery of compliant parts; knowledgeable in AQL and incoming inspection.
- Support supplier management projects, reporting, and continuous quality system improvements.
Knowledge, Skills and Experience Required for the Role:
- Bachelor’s degree in a technical or scientific field
- Minimum 2+ years of experience in Quality Assurance or Supplier Quality Engineering.
- Strong written and verbal communication skills with English proficiency.
- Excellent listening skills, highly detail-oriented, thorough, and dependable.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
