The Supplier Quality Engineer will be responsible to proactively support quality engineering activities with regards to the Quality Management System Specifically Supplier Management under direct supervision of Director Global Supplier Quality Assurance.
Supplier Quality Engineer Responsibilities:
- Maintain oversight of current suppliers and assess potential new suppliers and service providers for technical, quality, and quality system capabilities.
- Implement continuous and innovative improvements with demonstrated and measurable results – e.g. Dock to Stock Program, Cost of Poor Quality
- Drive the supplier audit program through managing and conducting supplier audits per schedule.
- Evaluate nonconforming supplied material and prepared Supplier Correction Action Requests (SCAR) to effective resolution of root cause problems contributing to unsatisfactory supplier quality performance.
- Ensure supplier files are compliant with regulations and internal procedures.
- Liaise with Operations, Supply Chain Management, Warehouse, Engineering and PD to ensure uninterrupted supply of materials.
- Provide Operational QA Support for products and process.
- Degree in Quality, Engineering or Science discipline.
- 3-5 years’ experience at quality engineering level within a regulated industry, preferably the Medical Device Industry.
- Demonstrable knowledge of FDA 21CFR820 and/or ISO 13485 regulations.
- Audit experience in conduction supplier and or internal audits.
- Certified Lead auditor qualification for 13485 is an advantage.
- Knowledge in statistical methods.
- Familiarity with use of ISO 14971:2007 an advantage.
- Ability to communicate effectively with management and fellow peers, both orally and in reports.