南京招聘

Mission of Function：Ensure SSME XP quality system complying with relevant internatonal standards and relevant national regualtions such as ISO13485, MDD 93/42/EEC, 21 CFR part 820, CMDCAS etc, and ensure process house implemented in the organization,he/she reports to Quality director of SSME XP QA.

Dimensions of Function：Establishment and implementation of quality management system. Integration and implementation of process house. Assessment and continuous improvement of quality management system.
Regular reporting on quality target achievement and QMS performance to SSME XP QA director.
Organize the internal audit and support management review in SSME XP.
Responsible for coordination of external audit in SSME XP.

Contacts：
Internal: Working together with each process (from SSME XP and Supporting fuctions) on establishment and improvement of processes to fulfill quality system and regulatory requirements. External: Keep contacts with notified body and act as coordinator for external audits
A r e a s o f R e s p o n s i b i l i t y / T a s k s

Develop quality management system strategy and plan according to SSME XP business development needs and technology development trends.
Identify required international standards and relevant national regualtions for quality management system.
Establishment of quality management system complying with identified standards and regulations, implementation and maintenance of quality management system in SSME XP.
Integration and optimization of processes in quality management system according the principle of process house
Plan and organize internal audits and management reviews, initiate continuous improvement process.
Organize SSME XP CAPA meeting and make sure the CAPA process in SSME XP is running smoothly. Resposible for following up the agreed CAPA actions in limited time limits.
Responsible for coordination of external audit in SSME XP like TUV audit, CFDA audit, FDA audit. Lead the preparation of external audit.
Monthly report on the performance of quality management system implementation, define necessary actions including resources to continuously improve the effectiveness of quality management system.
Organize necessary quality (refresh) trainings for employees.
Act as a consultant for quality regulations in the organization and a coordinator for external audits.

"Education: University and above
Experience: With 3 ~ 6 years experience in quality engineering field. Have the experience of FDA audit."

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