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工作职责

? Responsible for Adverse Event Reporting in China
? Responsible for material hold process (own products, distributed products)
? Responsible for complaint handling and complaint investigation for medical
devices
? Responsible for Field Safety Corrective Action process in China
? Analyze safety data and advise appropriate recommendations to prevent new
or recurring incidents
? Responsible for compilation Periodic Safety Update Report for manufactured
and distributed devices
? Directly accountable for the Supplier Quality functional procedures
(Process Owner), systems, KPIs and associated process improvements to achieve
and sustain a compliant and efficient supplier management process that assures
the quality of products to our sites and customers.
? Ensures supplier and material qualifications occur according to program
timelines.
? Becomes a qualified lead auditor and performs supplier audits. Ensures
supplier audit program requirements are fulfilled.


任职要求

? Proven ability to work collaboratively
? Project management skills would be preferable.
? Strong communication and interpersonal skills with ability to work well in
high pressure environment
? Recommended 3-5 years of experience in supplier management, complaint
management or medical device manufacturing.
? Bachelor's Degree (ME, EE or equivalent)
? Direct experience within the medical device industry is preferred.
? Proven ability to demonstrate technical writing skills
? Proven knowledge in application of quality engineering
? Working experience in environments under ISO 13485