北京招聘

职位描述：
职位职责 (简要说明)
? Ensures that the local Quality Management System meets current regulatory requirements and comply with local business operation;
? Lead Development and/or Improvement of Quality system;
? Improve and optimize the corrective action and preventive action system.

主要工作内容/职责（列举清单）
? Ensures that the local Quality Management System meets current regulatory requirements and comply with local business operation;
? Ensures Cooperate policies are implemented within local SOPs within the local QMS as appropriate
? Assist with development and/or Improvement of Quality System procedures and processes;
? Assist with internal and supplier audit development, implementation, and execution;
? Provide support to internal functions in the application, maintenance and improvement of medical quality systems and department specific processes;
? Improve and optimize the corrective action and preventive action system for medical projects to ensure the compliance of FDA QSR820, ISO 13485:2003, etc.;
? Responsible for managing 3rd party audit, regulatory compliance agency inspection;
? Document control management for medical project;
? Other tasks assigned.

任职资格
知识/教育程度
? Bachelor’s Degree in Engineering, Science, or health-related field
? Familiar with Quality system Improvement tools, such as 8D, fish bone, 5why，etc.
经验/能力要求
? 3-5 years related work experience in Quality Management system, at least two years’ experience as quality system engineer or above.
? Quality Systems development, implementation, and training experience
? Experience with ISO 9001, TS 16949 system requirements and training, ISO 13485 is preferred.
? Must be able to work independently and have ability to work with cross-functional teams
? Extensive project management skills with the ability to work under tight timelines and able to multi-task
? Must have an understanding of fundamental quality system processes for design, CAPA and manufacturing in a regulated industry.
? Familiar with MS-OFFICE;
? Good communication and team work;
? Fluency in oral and written English. 举报 分享

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