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工作職責(zé) Conduct incoming inspection of disposables including particle verification. Conduct incoming inspection of purchased material for conformance to specifications for injectors Verify accuracy of labelling and certification content to material requirements Report on (in-production) non-conforming product levels of disposables and injectors Conduct production final QC inspections and product verification testing for injectors. Collect data, summarize, analyze, and perform basic statistical analysis on results. Approve or reject items, and record inspection and disposition information of injectors Accountable for QC Release processes for injectors Support material and supplier qualification processes as appropriate Set-up processes to ensure release processes for sterile disposables are compliant to external regulations (Process Owner) 任職要求 Proven ability to work collaboratively in a manufacturing environment. Recommended 3-5 years of experience or above Bachelor's Degree (ME, EE or equivalent) Direct experience within the medical device industry is preferred. Desirable ISO 13485, EU MDR