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SHDM 质量控制经理 Quality Control Manager

Job Description

任务/职位简述 Mission/Position Headline:
This position will be responsible for leading the Immunoassay (IA) Quality Control department for the manufacturing facility located in Shanghai. This includes staffing, developing, and training the IA Quality Control teams as well as supporting all activities to enable product transfer and plant readiness for product manufacturing, registration, launch, and continuous commercial production
本岗位负责上海免疫发光试剂工厂的所有质量检验活动,保证产品转移过程中及正常生产中各检验活动的顺利进行。主要工作内容有人员招聘,人员发展及针对免疫发光平台产品质量检验团队的能力培养。 

职责领域 Areas of Responsibilities:
• Implementing strategic planning proposals for modeling US Manufacturing operations within the Shanghai facility to meet China Regulatory Requirement including EHS and Quality reqreuiement
基于中国安全及质量法规要求和美国转移方生产运营方式,策划质量检验运营团队及相关活动。

•      Establish and Develop the detailed Immunoassay Quality Control organizational structure to support product and production transfer and registration timelines,including but not limited to 
o Creating job requisitions, interviewing, hiring of personnel
o Direct supervision and management of personnel
o Develop team capability to meet business requirement 
建立免疫产品质量检验团队,支持产品转移活动,满足项目及注册时间要求,包含但不仅限于
o 建立岗位职责,面试并招聘团队
o 对QC人员进行管理
o 持续发展团队以满足业务需求

• Managing and providing oversight of the Quality Control department which includes Incoming Inspection, Microbiology, and In-Process & Final QC Release Testing, including but not limited to 
o Establish quality procedures to instruct detailed activities 
o Development training program for each positions 

管理并统一协调质量检验部门相关工作计划,包含进货检验,微生物检验,过程及成品检验, 包含但不仅限于
o 建立质量文件指导具体检测工作
o 建立培训矩阵,确保人员培训到位

• Collaborating with Quality Assurance, Manufacturing, Technical Operations,  and Engineering to support facility needs
与QA,生产,技术,工程部合作以满足工厂相关活动需求

• Interacting with US Operations and being responsible for production flow, operations process understanding, and business critical problem solving relating to:
o Immunoassay In-Process and Final Release Testing QC operations
o Incoming Inspection 
o Microbiology
与转移方运营团队联系,理解生产工艺,运营过程,解决关键问题,包含但不仅限于
o 产品过程检验及成品最终放行检验
o 进货检验
o 微生物检测

• Other related projects or tasks assigned by superior or company
完成其他上级指定的相关项目及任务

经验Experience
• 6年以上相关工作经验(有IVD行业经验者优先)
Typically 6+ years of successful experience in a directly related field and successful demonstration of Key Responsibilities and Knowledge as presented above (IVD experience a plus).
• 有项目及人员管理经验, SAP、LIMS等实验室数据管理经验
Demonstrated Project and Personnel Management experience. Demonstrated computer system experience such as SAP, LIMS etc. 
• 有质量工程师、质量管理体系、实验室认证等相关经验优先
Quality Assurance, QMS system and lab certification experience are preferred.


教育Education
• 化学、药学、食品科学/工程、生物化学或其他相关专业本科或以上学历
Bachelor’s degree or above in Chemistry, Pharmaceutical, Food science/Engineering, Biochemistry or related discipline or Diploma.
• 硕士及以上学历或相关工作经验者优先
An advanced/graduate degree or equivalent experience is preferred.

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. 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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