SHDM Sr Quality Engineer Pipeline

Job Description

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. 
We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. 

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. 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。 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. 
2. 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; 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; 
3. 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; 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; 
4. 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。 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. 
5. 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。Leading 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

• 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。
A 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.
• 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。
Individualy handling Quality Engineer activities in at least 2 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.

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

Our global team: 
We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our culture:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.
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 Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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