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苏州地区美资企业高薪招聘一名QA Engineer
待遇:依据能力,10000~13000
工作时间:5*8
联系方式:站内短信或者QQ:8642508
具体要求如下:
Experience 1. A minimum 5 years’ experience in aquality / regulatory environment with 2 or more years in Research andDevelopment quality area. 2. Multinational company experience is aplus.
Skill / Knowledge / Abilities 1. Familiar with GMP, GLP, QSR, MDD, ISO,510K, etc. 2. Knowledge of In Vitro Diagnosticproducts. 3. Good command of English and Mandarinboth verbal and writing. 4. Problem solving and priority setting. 5. Self-motivated, initiative and able towork under pressure. 6. Interpersonal skills and the ability towork effectively within diverse cultural environments.
Responsibility: 1. Lead Research and Development team intocompliance with Design Control procedures. 2. Ensure appropriate Design Inputs andDesign Outputs in evidence for project and adequate documentation andtraceability are provided in the Design History File. 3. Ensure robust verification, validation,product designs and design review processes are established. 4. Ensure appropriate training is inevidence for Design Teams on Design Control and Quality Systems. 5. Provide guidance to Research andDevelopment team on compliance with requirements for ISO 13485, European MDD,FDA / QSR, & SFDA regulations. 6. Provide support for stability studiesduring design phase. 7. Provide support for change controlassessment to define applicable design control elements are carried out. 8. Support risk assessment activities: FMEA(Failure Mode Evaluation & Analysis) & Control Plan etc. 9. Partner with regulatory team for initialregulatory review in support of design change requests. 10. Maintain system and provide oversightof design team activities to identify critical-to-quality design features andensure adequate control plans for product and process designs to demonstrateproduct is ready to market & manufacture on an ongoing basis.
附件内容同上,有兴趣的可以下载
JD of Senior QA Engineer.docx
(12.53 KB, 下载次数: 55)
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