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SSMR MR 质量过程管控工程师/Quality Risk Management Engineer

Job Description

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this greater cause. It reflects their pioneering spirit, combined with our long history of engineering in the ever evolving healthcare industry.

We offer you a flexible and dynamic environment where you have the space to stretch beyond your comfort zone in order to grow personally and professionally. Sound interesting?


Then come in and join SSMR as  质量过程管控工程师/Quality Risk Management Engineer to inspire the future of healthcare.


工作职责:

1.         Act as process owner of risk management & coach R&D. Ensure the Product Risk Management process complies with all necessary Regulatory Standards e.g. QSR (FDA), MDD and ISO requirements

担任风险管理流程的负责人和具体培训研发同事的能力。确保产品风险管理流程满足所有法规的要求,如QSR(FDA),MDD和ISO的要求。                                        

2.         Lead the risk management team on developing and approving Risk Management Files according to ISO14971, which includes risk management plan, product risk analysis, risk mangement report and risk assessment for individual function.

根据ISO14791,领导风险管理小组一起创建和批准风险管理文件,包括风险管理计划书,产品风险分析,风险管理报告以及风险评估所涉及的具体的个别功能等。                                                       

3.         Provide technical knowledge to the Risk Management Program including contributing to develop design and process FMEA’s for all manufactured products.

在风险管理方面,对于生产的所有产品提供技术支持,包括参与编写设计和工艺的FMEA。                                               

4.         Manage and oversee the implementation of effectiveness regarding Corrective & Preventive Actions as they pertain to the risk management program.

审查和监控出于履行风险管理所需要的措施,保证其的实施和有效性。                                         

5.         Before release for volunteer scanning, perform risk assessment on the prototype system.

需在发布给志愿者测试前,对样机进行安全风险方面的评估。                                         

6.         Work together with DCU to handle the safety complaints.

发生安全投诉时与DCU进行密切的合作。                                                      

7.         Provide internal trainings for product risk management.

在SSMR内部提供产品风险相关的培训。                                      

8.         Perform product risk management activities and reports for post market surveillance.

   完成产品上市后市场的风险管理活动和报告。                  



任职要求:

  1. Bachelor degree, Engineering background is preferred.                                                                
  2. At least 3 years working experience in R&D, CS or QM.
  3. Active, self-confident and convince capability, good analysis, result orientation, team work, communication skill, Fluent English.                                                  
  4. Knowledge for MR technology is preferred and relevant standards and method, e.g. ISO14971, IEC60601-1, FMEA                   


Being part of our team:

Siemens Healthineers is a leading global medical technology company. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.


Curious about our culture?

Our culture embraces different perspectives, open debate and the will to challenge conventions. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas and celebrate success.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.


To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.


Organization: Siemens Healthineers

Company: Siemens Shenzhen Magnetic Resonance Ltd.

Experience Level: Experienced Professional

Job Type: Full-time

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