上海 [切换城市] 上海招聘上海质量管理/安全防护招聘上海供应商管理招聘

SQA ENGINEER

锐珂医疗-上海工厂

  • 公司规模:1000-5000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2015-02-09
  • 工作地点:上海-浦东新区
  • 招聘人数:1
  • 工作经验:3-4年
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位月薪:面议
  • 职位类别:供应商管理  

职位描述

岗位职责:
1. Quality System:
1.1 Maintain the documented work instructions in documentation control system, ensure the documentation are clear and comply with company quality system and ISO13485 requirements.
1.2 According to the findings of internal and external audits, provide corrective and preventive actions, implement actions and close findings in time.
1.3 Participate the internal audit and accompany external audits, for critical components of regulatory requirements, communicate with suppliers and require suppliers to submit relevant C.O.C or other documentation to prove the compliance.

2. New Projects:
2.1 Early involve in DFM/ DFA review in the NPI stage.
2.2 Discuss part QPL with supplier, make sure the QPL is implemented effectively
2.3 Set up parts incoming inspection instructions and train inspectors and technicians.
2.4 Arrange inspectors to perform FA inspection, and communicate the inspection result with supplier and related people.
2.5 Communicate the part’s defect with supplier, drive supplier to analyze the root cause and drive supplier quality improvement in time to meet the quality goals of mass production.
2.6 Verify the quality inspection report provided by supplier, and raise requirements for supplier outgoing inspection and report.
2.7 Review nonconforming material upon nonconformity report.
2.8 Prepare reports related to supplier quality in time, in order to meet the project’s progress needs.
3. Mass Production Product:
3.1 Feed back the nonconformity information found in daily incoming inspection and production line to supplier through nonconformity report.
3.2 Lead the failure investigation, drive supplier and internal manufacture& design departments to analyze the root cause of failures, and take actions to prevent reoccurrence.
3.3 Monitor the status of nonconforming material, communicate with supplier in time and get supplier conformation, then inform buyer to return the nonconforming material.
3.4 Drive supplier to analyze the root cause of nonconforming material found in incoming inspection and production line, and take corrective and preventive actions to prevent reoccurrence.
3.5 If the material failed installation is returned to plant and need supplier to analyze the failure cause, communicate with supplier and get failure analysis in time. If needed, drive supplier to take actions to prevent reoccurrence.
3.6 Cooperate with purchasing department to accomplish part localization or verify source change with manufacturing engineer.
3.7 Communicate with supplier quality engineers in other sites to improve supplier quality improvement together.
3.8 Maintain incoming inspection plan, modify inspection plan in time when there is an engineering change.

4. Engineering Change and Supplier Change
4.1. Participate in review and approval of engineering change from SQA’s view.
4.2. When introduce a new supplier, cooperator with purchasing department to finish new supplier assessment. (Optional)
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任职要求:
1. Education, Professional experience:
· Bachelor’s degree


2. Technical knowledge:
· A minimum of three to 3 years in supplier quality area. Familiar with manufacturing processes of major basic industries, such as machining, plastic injection molding, metal surface treatment, PCBA, etc.
· Familiar with Quality tools.
· Familiar with applicable Quality Management Systems for medical devices.

3. Personal characteristics:
· CET-4 is must, CET-6 IS PREFERRED
· Certified ISO9001 internal auditor, ISO13485 internal auditor is preferred
· Good communication skill and co-ordination skill
· Strong team work spirit
· Six Sigma knowledge is preferred

4. Languages:
English: Fluent spoken and written Mandarin: Fluent spoken and written

5. PC-Knowledge:
Fluent Windows / MS Word / MS Excel/Power point

公司介绍

Carestream Health公司成立于2007年,是位于加拿大多伦多的Onex公司收购伊士曼柯达公司医疗集团后组成的。 2011年的总收入近25亿美元。

Carestream Health公司拥有8,100多名员工,为全球150多个国家的数万名客户提供优质的医疗产品。公司拥有1,000多项技术专利,产品在全球90%的医疗机构中运转。在医疗信息管理解决方案(Carestream Solutions),数字获取解决方案(Digital Capture Solution),数字输出解决方案(Output Solution)以及数字乳腺放射成像解决方案及牙科系统,各种数字和传统X光胶片产品在内的多个领域中,Carestream Health公司凭借丰富的整合方案以及专业全面的服务体系已经成为医疗数字成像市场的领导者。

Carestream Health公司在中国成立了锐珂(上海)医疗器材有限公司和锐珂(厦门)医疗器材有限公司,2009年又成立了锐珂亚太投资管理(上海)有限公司。依托柯达品牌百年来所积累的宝贵经验,通过充满激情、以客户为中心的团队,将不断追求技术发展和创新,为客户提供最新的医疗解决方案与技术,帮助从最小的诊所到最大的医院等各个医疗机构实现长期彻底的投资回报和应用保障。

     中国区总部设在上海
     设立了17个办事处
     1个研发中心
     1个技术创新中心
     2个工厂,其中上海工厂主要用于医疗设备生产,厦门工厂主要用于医用胶片生产
     员工约1400名

    创新而又成功的丰厚历史,以及优秀的企业文化和巨大的发展机遇,使您在锐珂医疗的工作充满兴奋和喜悦。同时我们把员工看作是最宝贵的财富,一经录用,我们将提供极具竞争力的薪酬福利待遇和职业发展培训:

     具有行业竞争力的薪金
     社会保险及商业保险
     带薪年休假及全薪病假
     年度旅游及员工俱乐部
     节假日福利
     针对个人职业发展的培训

    请访问公司网页: www.carestream.com 获取更多公司信息。

Carestream Health was found in 2007 by Onex, as an independent subsidiary of Onex Corporation of Toronto. Onex acquired the Health Group of Eastman Kodak Company in a multi-billion-dollar transaction. As an independent subsidiary of Onex Corporation of Toronto, Carestream Health recorded 2011 revenues of almost $2.5 billion.

There are more than 8,100 employees all of the world and Carestream Health owns more than 1,000 patents for technology and intellectual property. Our products and services are present in 90% of hospitals worldwide. Depending on the abundant integrated plans and professional service system, we have become the leader of healthcare IT solutions market, including Carestream radiology solutions and information management solutions (RIS-PACS,EIM), CR, DR, CAD (computer aided detection) systems, laser imagers, services, mammography and oncology solutions, and a range of digital and traditional film-based dental products.

Carestream Health established Rayco (Shanghai) Medical Products Company Limited and Rayco (Xiamen) Medical Products Company Limited in China and established Rayco Asia Pacific Investment & Management (Shanghai) Company Limited in 2009. Relying on the centenary experiences accumulated by Kodak, through customer-oriented team with full enthusiasm, we always seek further technical developments and innovations, and supply our best solutions and techniques to help both clinics and hospitals achieve their long investment returns and applied services.

        *China headquarter is at Shanghai
        *17 offices all around China
        *One Global R&D Center at Shanghai
        *One Asia Technology & Innovation Center at Shanghai
        *Two factories in China, one is at Shanghai for medical equipment, the other is at Xiamen for medical film
        *Nearly 1,400 employees in China

        With the creative and successful history, the good company culture and great opportunities. It will be excited and cheerful to work at Carestream Health. The employee is the most valuable wealth for us, if hired, we will offer you competitive compensation and benefits:

        *Competitive Salary
        *Social & Business Insurance
        *Annual Leave & Sick Leave(full pay)
        *Outing & Staff Club
        *Festival Benefits
        *Personal Training Opportunities

        For more information, Please visit: www.carestream.com

联系方式

  • 公司地址:地址:span上海市浦东新区金桥出口加工区川桥路1510号第七幢厂房