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SHDM Senior Quality Engineer 高级质量工程师

Job Description

Responsibilities:

l  Leading or participation on  validation and qualification activities, such as SVMP, validation protocol and report, execution monitoring for process, equipment, facilities and utilities. Will work closely with the other project core team leads/functions to ensure that processes are appropriately qualified/validated in a timely manner. 领导或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。 

l  Leading or 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.领导或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。

l  Leading or 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.领导或参与风险文件转移,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。

l  Leading or participate on operational quality activities, such as nonconformity, deviation, change control, supplier quality management, product release; Ensure operational quality related activities meet company Quality Requirements.领导或者参与不合格、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。

l  Leading establishment on process of post-market quality activities, such as complaint, Field Actions, Adverse Event, etc.领导建立后市场质量活动流程,如投诉、现场行动、不良事件等。

l  Other related projects or tasks assigned by superior or company.其他上级或公司分配的项目或任务。

Education and Experience

l  Minimum of 5 years in medical device , biotechnology or pharmaceutical industry, with a Quality Engineer role.  Majority experience in at least 3 of 5 areas and have some experience or knowledge of other two.至少5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(至少3-5个)有相关经验或知识储备。

l  Individual handling Quality Engineer activities in at least 2 areas and have experience of activities in other area with guideline from others.能在至少 2 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

l  Have product transfer experience or manufacturing establishment experiences are preferred.有产品转移经验或生产建立经验者优先。 

l  Minimum of a 4 year degree is required.本科学历。  


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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