美资医疗器械公司诚招产品质量工程师--上海浦东

Job responsilities:

1. Identify Quality Plan and Conduct Quality coordination with Project Management tools for product commercialization and Transition.
2. Set up applicable quality goals with interested parties, like in-line DPU, OOBQ, on time delivery rate, etc.. through proper co-ordination. Conduct biweekly quality review with Contract Manufacturer, push CAPA to assure quality goals are reached.
3. Ensure design transfer to manufacturing by working together with design, manufacturing, sourcing etc..
4. Track each OOBQ failures, push CAPA for it.
5. Implement applicable test items from design outputs to assure product quality for in-house building products.
6. Develop FGA procedure. Conduct finish good audit ensure product quality for in-house building products.
7. 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.
8. Support regulatory function to keep Regulatory and Safety compliance, especially for OEM products.
9. Implement IPQC audit periodically for both in-house and OEM products.
10. Support ISO audit, get involved in HSE, Lean activity

Qualification：
Over 3 years working experience of QA position
Working experience in Medical Device Field is a plus
Mechanical background is preferred

For interested candidate, pls send your resume in both English and Chinese to yuechu.yu@gmail.com