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BD (Becton, Dickinson and Company) 高级品管工程师-QA-苏州-苏州一厂 in Suzhou Plant 1, China

Job Description Summary

Job Description

  1. Working with new product project team to setup or transfer quality control plan from design center and/or other manufacture sites for new products launch.参与新产品项目,从研发或其他生产厂转移新产品质量控制;

  2. Provide GMP/plant quality system requirements as expertise input to product design/documentation. 在新产品转移项目产品设计/文档方面提供GMP/工厂体系要求的专业输入。

  3. Leadership and conduct the plant owned validation and MSA for projects as required领导工厂执行的工艺过程验证,测试方法验证工作

  4. Compilation of quality documents required for product registration requirements 编辑产品注册要求的质量文件

  5. Prototype product release review.注册产品放行审核

  6. Participate competent authority on-site audit for product registration/surveillance purpose参加监管当局的现场审核

  7. Establish or transfer the measure method for raw material inspection, in-process inspection and functional inspection.

负责建立或转移原材料进货,过程,产品功能试验的试验方法。

  1. Coordinate with project team, to conduct the risk analysis and setup related control plan.

与项目团队合作,完成相关风险分析并建立对应的控制计划

  1. Handling the non-conformance control, ensure the effective corrective action and preventive action implemented via deviation management.负责不合格控制,确保纠正措施及预防措施的有效性。

  2. Complete other related work.完成交付的其他相关工作。

Primary Work Location

CHN Suzhou Plant 1

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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