Brief Description of Job Function：

1. Identify Quality Plan and Conduct Quality coordination with Project Management tools for product commercialization and Transition.
2. Set up applicable quality goals with OEM suppliers, like in-line DPU, OOBQ, on time delivery rate, etc.. through proper co-ordination. Conduct biweekly quality review with OEM suppliers, push CAPA to assure quality goals are reached.
3. Set up sampling plan for FGA on site for OEM manufactured finished goods and make sure it’s implemented accordingly.
4. Track each OOBQ failures, push CAPA for it. Report CAPA to service team and track OEM supplier’s CAPA through SPS system.
5. Act as a co-cordinator for quality dis-agreement between Rayco & OEM supplier.
6. Implement applicable test items from design outputs to assure product quality for in-house building products.
7. Develop FGA procedure. Conduct finish good audit ensure product quality for in-house building products.
8. Keep tracking of in-house product quality performance for both in-line and installation issues. Provides analytical and statistical information to assure quality products and services.
9. Support regulatory function to keep Regulatory and Safety compliance, especially for OEM products.
10. Implement IPQC audit periodically for both in-house and OEM products.
11. Support ISO audit, get involved in HSE, Lean activity

Education &Knowledge Required：

Bachelor degree of Science or Engineering

Experience Required：

Over 2 years working experience of QA position
Working experience in Medical Device Field is a plus

PC Software Required：

Microsoft office tools.

Language Required：

Fluent in both English and Chinese

Other Special Requirement：

Special course : Six Sigma training
Good communication skill and co-ordination skill
Strong team work spirit