西安
2019-03-02
6次
质量工程师
8K-10K/月
强生医疗器材有限公司
申请职位
基本信息
工作性质全职
职位类别销售代表
招聘人数10人
学历要求大专
工作经验1-3年
性别要求
年龄要求不限
招聘部门不限
工作地点苏州工业园区长阳街299号 (邮编:215021)()
联系方式
联系人:强生医疗器材有限公司  ( 联系我时,请说是在我爱工作网上看到的 )
联系电话:154****9834
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职位动态
100%
近两周该职位的简历处理率
简历处理率
0天
简历平均处理时长
01-22 11:47
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职位描述
Scope may include, but are not limited to:
  • The Quality Engineer utilizes Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.
  • The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.
  • He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.
  • This person will support processes in base business.
  • The Quality Engineer conducts assignments encompassing complete projects or portions of major projects.
  • They determine methods and techniques to be used or adapt standard methods to meet variations.
  • They coordinate phases of work internally and externally.


Product Quality, Control & Disposition and Performance Standards:
  • Accountability and ownership for semi-FG, FG, & Raw Material Review, as well as material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
  • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
  • Conduct investigation, bounding, documentation, review and approval of NCs, CAPAs and customer complaints. Escalation of quality issues as appropriate.
  • Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
  • Support IQ, OQ, PQ, TMV or Software Validation
  • Compliance/Regulatory
  • Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the China GMP, ISO 13485, etc.
  • Support internal and external audits.
  • Support periodic line audits to assess for production controls. Review results of area audits to ensure that corrective and preventive actions are adequate.
Requirements:
  • Bachelor degree or above
  • Good communication skills in both Chinese & English
  • 2~4 years related working epxerience  is required, good knowledge of Mechanical drawing interpretation, good at Statistical analysis tools
  • GMP background is preferred

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