Job Title: Supplier Quality Engineer
Location: Galway, Ireland (Permanent) Hybrid Role
Company: CREGG
We are seeking a highly skilled and experienced Supplier Quality Engineer to join our team in Galway.
Key Responsibilities:
1. Responsible for ensuring the quality performance of sourced finished medical device manufacturers (OEM and Contract Manufacturers).
2. Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, risk assessing, prioritizing, and resolving quality issues.
3. Investigates and solves non-conformances due to incoming inspection.
4. Supports investigation of material quality issues/complaints as they arise and ensures that adequate corrective actions are identified, implemented, and controlled by Suppliers.
5. Reviews and approves supplier corrective action plans and verification of effectiveness documentation through SCAR ownership.
6. Plans and leads supplier assessment to assess compliance with regulatory standards and requirements.
7. Technical Team Member partnering with Supplier Engineering and Commercial Sourcing for multiple aspects of Supplier Management supporting objectives of the team in terms of Quality, Cost, and Service including Supplier originated changes, design, and labelling changes.
8. Supports sustaining quality issues, process change impacts, and design change implementations for suppliers within their Quality system.
9. Team member of New Product Development (NPD) projects with responsibilities for execution of applicable SFMD Plan deliverables and collaboration with cross-functional new product development teams to onboard finished medical device suppliers.
Education & Experience:
* Level 8 Degree in an Engineering or Technical Discipline.
* 4+ years of related work experience in the regulated industry including demonstrated understanding of QSR and ISO standard requirements for Material/Purchasing Controls, Product Realization, Validation, and CAPA.
* Good communicator skills & stakeholder engagement.
* Knowledge of Medical Device regulations, specifically Material Controls Quality System requirements. ISO13485 advantageous.
* Familiarity with Drug coated products advantageous.
Benefits:
* Paid Holidays.
* Canteen.
* Parking.
* Pension.
* Bonus.
* Permanent Health Insurance.