Job Description

Introduction section

At Fresenius Medical Care, we are the world's leading provider of products and services for individuals with renal diseases. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 112,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation

Information about plant:

At our Changshu plant in China, we manufacture life-sustaining products that support dialysis patients around the world. Our portfolio includes dialyzers, bloodline sets, dialysis solutions, hemodialysis machines, and key medical components. Using advanced technologies such as injection molding, extrusion, and automated assembly, our teams help ensure the highest standards of quality and reliability. Join us and become part of a global team committed to creating a future worth living for patients worldwide.

Job Specifications:

工作职责权限:

1、 Responsible for new product introduction and product localization projects;

负责新产品导入和本地化项目；

2、Responsible for production concept study and process creation, and related tools/equipment definition;

负责生产概念研究和生产工艺创建，以及生产相关的工具、设备的定义；

3、Preparation of process documents, production SOP, Flow Chart, DHR and other production related documents.

编制工艺文件，生产SOP，流程图，DHR等生产相关文件。

4、Responsible for the implementation of the production process validation.

负责生产过程确认的实施。

5、Able to do the production process, calibration and quality control effective, make sure the quality, avoiding the customer complaints.

确保进行有效的生产过程控制和质量控制，确保产品质量；避免客户投诉。

6、Take on site 5S & WIP(Work In Process) management, feedback abnormal issue, such as material shortage, non-conformity material, etc , make sure the production environment and action orderly and clean.

进行现场5S和WIP（在制品）的管理，反馈异常状况，如缺料，材料不合格等，确保生产现场和生产活动能够井然有序。

7、Operate all manufacture machine, Master machine's working theory and know current situation and report regularly. Analysis the reason of equipment shut down or alarm and analyses alarm data.

能够操作所有的生产设备,熟练掌握设备的工作原理，了解掌握当前设备的运行情况定期汇报。自动化设备故障排查，报警处理，报警数据分析。

8、Cross functional communication as required, like ENG. QM, and Logistics etc. to resolve problems.

适当时需要进行跨部门沟通，合理解决车间相关问题。

9、Improvement and optimization for machine or production procedure, content include production efficiency, procedure, safety, quality ect., detailed plan and activity needed and final need assessment for benefit.

提高并且优化设备或者生产流程,内容涉及生产提高生产效益，生产流程，安全，质量等等，需要具体的执行方案和实际行动，最终需要对收益进行收益评估。

10、Responsible for related production process investigation or CAPA for customer complaints.

负责生产过程相关的客户投诉调查，CAPA等。

11、Responsible for design transfer on the production side.

负责生产端的设计转移工作。

12、Any other duties assigned by bloodline assembly manger.

任何上级指定的其他工作。