Work Flexibility: Onsite

Responsible for ensuring that processes needed for the Quality Management System are established, implemented and maintained and assist department head to ensure the promotion of awareness of regulatory and customer requirements throughout the organization. Creates and drives a culture of Quality and Compliance.

负责确保质量管理体系相关流程的建立、执行和维护，协助部门主管提升组织内法规和客户要求的认知， 建立和推行质量和合规文化。

Continuously fully comply with all GMP and Regulatory requirements.

持续完全符合所有的GMP和法规要求

Responsible to stop further processing in the event of encountering non-conforming products condition

当发生不合格产品时，负责停止进一步流转 . 

Provide guidance on Quality Assurance/GMP/FDA-QSR related topics

为质量保证/GMP/FDA/QSR等相关要求，提供指导方针

Implement Stryker Corporate Quality policies and standards. Ensure compliance to GMP and ISO requirements

执行史赛克总公司质量政策和标准，确保符合GMP和ISO要求

Ensure sufficient processes are in place and being followed for the transfer, production, and monitoring of product quality

确保所有流程是适当的并在生产中被执行， 监控产品质量，包括但不限于检验作业指导书和检具及检验设备管理。

Involved in developing, modifying, and executing regulatory related company guidelines and procedures.

开发，修改和执行公司相关指导方针和流程

Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of company products.

定义、说明和/或批准检验测试标准、方法、程序的执行， 并评估公司产品的精确度、准确度和可信赖度

Involved in developing, modifying, and executing regulatory related company guidelines and procedures.

参与法规相关的公司质量方针和程序的建立、修订和执行

Will train others on GMP, ISO, Quality Assurance/Regulatory Affairs topics.

对员工进行GMP、 ISO、质量保证、法规培训

Will attend internal Quality Assurance/Regulatory compliance audits and communicate results.

参加内部质量、法规审核并沟通结果

Be involved or leads and implements the Lean philosophy – standardization and elimination of waste.

参与或领导并执行精益理念-标准化并减少浪费

Fully authorized to “release” or “Reject” product,        component, process, and so on according to QS requirements.

根据质量体系要求，全权处理“放行”或“判退”产品、部件、过程等。

Other tasks assigned by supervisor

主管分配的其他任务

Travel Percentage: None