KH
Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
🇬🇧 United Kingdom | 🇺🇸 United States
Hybrid
Mid level
4 months ago
- SAP
- ERP
- Windchill
- Change Management
- CAPA
- GMP
4 months ago
We are seeking an experienced Supplier Quality Engineer with a strong background in the Medical Device industry to support supplier quality, incoming inspection, and manufacturing quality initiatives.
Roles & responsibilities :
- Drive supplier quality and incoming inspection activities
- Analyze material non-conformances and work directly with suppliers on resolution
- Support component selection, qualification, and reliability assessments
- Review product designs for quality and manufacturability
- Lead supplier investigations, root cause analysis, and corrective actions
- 5+ years of experience in Manufacturing Engineering, Supplier Quality, or Quality Engineering within Medical Devices
- Hands-on experience with Supplier Quality Engineering, Receiving Inspection, and supplier management
- Experience with SAP (Quality/Supply Chain modules) or similar ERP systems
- Knowledge of Windchill or other document control systems for change management and BOM updates
- Experience developing inspection procedures, quality plans, and inspection tooling
- Ability to support component qualification, testing, validation, and approval activities
- Strong collaboration with Design Engineering on component quality, reliability, and manufacturability
- Experience investigating supplier-related quality issues, material defects, and corrective actions (CAPA)
- Knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971
Supplier Quality Engineer · Katalyst Healthcares & Life Sciences