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SHDM (Sr.) Quality Engineer(高级)质量工程师

Job Description

任务/
职位简述 Mission/
Position Headline:
这是一个质量工程 (QE) 职位,需要个人在受监管环境中(例如 IVDD、医疗设备、制药、生物技术等)的风险管理、设计、验证、制造和上市后质量活动方面的知识/经验。 作为中国扩张项目的一部分,担任此角色的个人将负责协调质量工程 (QE) 工作流。
This is a Quality Engineering(QE) position that requires an individual knowledge/experience on risk, design, validation, manufacturing and post-marketing quality activities in a regulated environment, e.g., IVDD, Medical Device, Pharmaceutical, Biotech, etc.  The individual in this role will be responsible for cooridanate the  Quality Engineering(QE) workstream as part of the China expansion project.
职责领域 Areas of Responsibilties:: 1. 参与在验证和测试活动,如SVMP、验证方案和报告、执行流程/设备/设施/公用设施监测。 将与其他团队密切合作,确保流程及时获得适当资格/验证。
Participation as Quality Function representative on  validation and qualification activities, such as validation protocol and report, execution monitoring for process, equipment, facilities and utilities of an IVD manufacturing facility to be built in China.  Will work closely with the other project core team leads/functions to ensure that processes are appropriately qualified/validated in a timely manner.     
2. 参与设计历史文件的转移;协调设计审查/生产转移审查;设计变更的审查和咨询;
Participate on design historical files transfer activities from sending site to receiving site; coordinating design review/manufacturing transfer review; reviewing and consultant for design change;
3. 参与风险文件转移,以及流程、设备、设施相关文件的起草活动;审查并就质量事件(不合格和变更)风险分析提供咨询;
Participate on risk files transfer activities from sending site to receiving site and drafting activities for process, equipment, facility; reviewing and consultant quality case(nonconformity and change) risk analysis;
4. 协调不合格、偏差、变更控制、供应商质量管理、产品发布等经营质量活动:确保运营质量相关活动符合公司质量要求。
Coordinate on operational quality activities, such as nonconformity, deviation, change control, supplier quality management, product release; Ensure operational quality related activities meet company Quality Requirements.
5. 参与建立后市场质量活动流程,如投诉、现场行动、不良事件等。
Participate on establishment on process of post-market quality activities, such as complaint, Field Actions, Adverse Event, etc.
6. 其他上级或公司分配的项目或任务。
Other related projects or tasks assigned by superior or company


职能范围/内容 Dimension of Function/Volume: SHDM

联系人 
(内部/外部) Contacts 
(internal/external):: SHDM相关部门,如生产、技术运营、工程和质量保证;美国工厂的相关部门。
Related functions in SHDM, e.g. Manufacturing, Technical Operations, Engineering and Quality Assurance; related departments in US site


教育和经验Education and Experience
经验Experience
• 至少3年医疗器械、生物技术或制药行业质量工程经验。对于上述大多数职责领域(2个以上)有相关经验或知识储备的人员优先。
A minimum of 3 years in medical device , biotechnology or pharmaceutical industry, with a Quality Engineer role.  Majority experience in more than 2 areas and have some experience or knowledge are prefered.
• 能在至少 1 个领域独立处理质量工程任务,并能在其他领域在他人指导下进行工作的经验。
Individualy handling Quality Engineer activities in at least 1 areas and have experience of activities in other area with guideline from others.
• 有产品转移经验或生产建立经验者优先。
Have product transfer experience or manufacturing establishment experiences are preferred.

教育Education
本科学历。A minimum of a 4 year degree is required.


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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