上海招聘

Main responsibilities & duties:
1.Ensure the suitability, adequacy and effectiveness of Quality System. Gap assessment with updated regulations. Identify improvement opportunity of quality system and lead relevant actions.
确保质量体系的适宜性，充分性和有效性。法规更新后进行差距分析。发现质量体系改进机会，并引领相应改进措施。
2.Arrangement and coordinate external audit from third party inspections.
安排协调第三方外部审核
3. Responsible for developing and executing the internal audit schedule, identification of areas in need of improvement, and verification of corrective actions.
负责建立并实施内部审核程序，发现改进机会，并验证改进措施。
4. Maintain the CAPA system, ensure the root cause is identified correctly and the effectiveness of corrective and preventive actions. Ensure the CAPA process goes through in a timely manner.
维护纠正预防措施系统，确保根本原因被正确识别和纠正预防措施的有效性。确保纠正预防措施按时执行。
5.Report Quality indicator on monthly basis
每月汇报质量指标

Job Requirements:
- Bachelor of Science degree in Physical Sciences or equivalent本科学历，物理或自然科学或类似背景
- Mechanical or Electrical education background as a plus机械或电子教育背景优先考虑
- 3 years working experience in Quality Compliance area 3年质量体系建立和维护工作经历
- have ISO13485 audit and SFDA audit preparation experience.具有ISO 13485和SFDA审核经验。
- experience with multi-national company as a plus具有跨国企业工作经历优先考虑
- Understand requirements of ISO13485, MDD, and QSR820
理解ISO13485，MDD和QSR820 要求
- Familar with SFDA medical device requirement.
了解SFDA医疗器械规范要求
- Understand product registration requirements and process as a plus理解产品注册要求和流程优先考虑
- ISO 13485 or YY/T0287 internal auditor as plus
具有ISO13485或YY/T0287 内审员资格优先考虑
- Fluent verbal and written English流利的英语口语和书写
- Good computer skill of Microsoft application software计算机操作（微软应用程序）
- Good communication skill and team spirit良好的沟通能力和团体合作精神

柯惠医疗器材制造（上海）有限公司即美敦力上海工厂（SMF）是美敦力在华独资的***家生产企业，成立于2006年11月，于2007年4月正式启用。公司坐落于漕河泾高科技园区，总投资4000万美金，总建筑面积达18，414平方米。其中10万级洁净车间面积为3000平方米，实验室总面积为500平方米。公司员工总数近340名，现生产产品16个品种，包括心脏瓣膜、医用高频仪器设备，腹部外科手术器械，手术室、急救室、诊疗设备及器具。
Medtronic Shanghai Manufacturing Facility (SMF) is Medtronic’s first wholly-owned manufacturing subsidiary in China. The site was founded in November 2006 and officially inaugurated in April 2007. With an initial investment of 40 million USD, SMF boasts a gross floor area of 18,414 square meters in Caohejing Hi-Tech Park. The site is composed of 3,000 square meters with Class-8 clean room and 500 square meters for laboratory use. There are currently 340 employees and 16 product lines producing
tissue heart valves, high-frequency medical equipment, abdominal surgery instruments, and diagnostic/treatment instruments used in the operation room and first aid.

公司每年平均引入1-2种新产品投入生产。2014-2015年与美敦力中国研发联手，成功推出基于微波消融技术的肝癌手术设备和新一代血管闭合与组织融合先进电外科设备。2016年公司更以1300万美元的投资额引入美敦力全球***的事业部-心脏业务集团的心脏瓣膜项目，以造福先天性心脏病、风湿性心脏病、冠心病、
心律失常或瓣膜退化、以及心脏血管病变等患者。2017年公司开始正式生产心脏瓣膜产品，预计每年将能够帮助中国和全球的65000名患者更及时地获得高品质的治疗。
SMF continuously expands its local manufacturing capabilities by adding one or two new products to its portfolio per year in average. In 2014 through 2015, collaboration between SMF and Medtronic China Technical Center successfully drove launches of the ablation technology based hepatic surgery devices and new generation of advanced electrosurgical instruments for vessel sealing and dividing. In 2016, 13 million USD was invested in SMF’s further evolvement to introduce the new tissue heart valve manufacturing line for the Medtronic Cardiac Vascular Group. The tissue heart valve material will contribute to helping patients who suffer from congenital, cardiovascular, coronary and rheumatic heart diseases. Starting 2017, the combination of our local and global heart valve manufacturing will help 65,000 patients improve their access to high-quality treatment in China and around the world.

美敦力上海工厂(SMF)致力于成为全球共享制造基地及区域性业务战略伙伴，提供世界一流品质的产品和服务，坚持人才培养，实现员工价值。
The Medtronic Shanghai Manufacturing Facility (SMF) is dedicated to becoming the global shared manufacturing site and regional business strategic partner that provides world class quality products and services, investing in talent development and realizing individual value for our employees.