上海招聘

Goals/Mission
- Ensure quality system complying with relevant international standards and relevant national regulations such as QSR, MDD, CMDCAS etc, and ensure process house implemented in the organization, he/she reports to head of the department.
- Establish, implement, assess and maintain quality management system. Integrate and implement process house.


Task
1. Process
- Establish quality management system of the BU complying with relevant standards and regulation. Ensure implementation of applicable standards and regulations in relevant processes.
- Implement quality management system in each process, and support further development of the BU quality management system.
- Integrate and optimize processes in quality management system according the principle of process house.
- Maintain Q-document, e.g., Quality Manual, quality procedures.
2. Audit
- Cooperate with the department for internal audit. Control corrective measures from audits.
- Coordinate and participate in external audits, e.g., TÜV.
3. CAPA
- Plan, prepare and organize quality meeting and management review within the BU periodically.
- Initiate and facilitate CAPA process in the organization and follow up of agreed actions. Ensure the effectiveness of CAPA.
4. Training
- Act as the BU's TRAC Administrator.
- Maintain training plan, ensure sufficient training assignment to employees.
- Ensure training effectiveness.

Education
- Bachelor or above
- Electrical, or Mechanical, or Engineering is preferred

Knowledge/Languages
- Quality management system knowledge
- ISO 9001, ISO 13485, MDD knowledge
- Audit skill
- Statistical technique
- Communication skill
- Train the trainer
- Language (fluent English, basic German will be better)

Experience
- Experience with establishment and implementation of quality management system and process management.
- Experienced with establishment and certification of ISO9001 and ISO13485 Quality System.
- Experience on work and communication with foreigner.
- 2~3 years quality related work experience
- Medical device related work experience


Note,
1. Location is at Nanhui, zhou pu;
2. More than 20 routes of shuttle buses will be provided.

上海西门子医疗器械有限公司(http://www.healthcare.siemens.com.cn/about-us-cn/healthcare-development-ssme-cn)成立于1992年，是西门子（中国）有限公司下属的独资公司。目前公司致力于计算机断层扫描诊断设备(CT)、X光机诊断设备、及其零部件的研发生产。相关客户服务也是我们业务的重要组成部分。公司并参与Soarian MedSuite 的全球研发及在中国的项目实施。公司被上海市政府授予高新技术企业称号。

上海西门子医疗器械有限公司不仅是西门子供应全球市场的医疗影像设备制造基地，而且是西门子医疗影像设备和医疗软件的研发中心之一。公司拥有800多名员工，其中研发人员超过270人。

上海西门子医疗器械有限公司位于上海国际医学园区（周祝公路278号），占地面积10万平方米，其中各类研发及生产区域占地超过35000平方，总投资超过3亿多人民币，是西门子医疗业务领域在亚太地区最大的研发和制造中心，也是目前上海最大的医疗器械研发生产高科技企业之一。

近几年来，公司发展尤为迅速。 CT业务部门成功研发制造了双层螺旋CT SOMATOM Spirit，以及6层16层螺旋CT SOMATOM Emotion系列。X光机部门则成功地向市场推出了中国热销的X射线拍片系统Aristos VX Plus等优质产品。

公司的客户服务部门，提供培训，区域技术支持及各类零备件的物流服务。

公司的医疗软件部门致力于研发和实施西门子全球化和本地化的Soarian MedSuite产品

公司将继续加大研发力度，为市场提供更多高品质的医疗设备和医疗软件，为健康水准的普遍提高作出积极贡献。

公司地址：上海市浦东新区周祝公路278号 邮　　编：201318

公司网站：http://www.healthcare.siemens.com.cn/about-us-cn/healthcare-development-ssme-cn

公司邮箱：recruitment_healthcare@siemens.com