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 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. Leading the CAPA process for the MAH (Process Owner) 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 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