MAIN PURPOSE OF JOB

主要工作目的

Start-up phase:项目阶段

• Provide strong support for production line transferring, guide the process validation implementation to comply with the quality system & relevant regulations，review and carry out actions to reduce the risk of process validation failure 支持生产线转移，指导过程确认的实施以符合相关质量体系和法规要求，评审并采取措施以降低过程确认的失败风险

• Build up testing capacity regarding products, including setting up inspection procedures, product specifications and qualify testing equipment. 建立和产品相关的测试能力，包括建立测试程序，产品标准并验证测试设备

• Set up and follow up the quality control plan 建立并跟踪质量控制计划

  Routine production:日常生产

• Perform WIP product release, and complete quality report 实施WIP产品放行，完成质量报告

• Identify NCs and CAPAs in a systematic way, e.g. using statistical tools 系统地识别不合格和CAPA，例如，运用统计工具

• Take responsibility for quality improvement 负责质量改进

  Cooperate with other Engineers for complaint investigation and close 与其它工程师协作完成投诉处理

  
  
  

JOB RESPONSIBILITIES

工作职责

Start-up phase: 项目阶段

• Take part in process validation. 参与过程确认

• Build up testing capacity regarding products, including setting up inspection procedures, product specifications and qualify testing equipment. 建立和产品相关的测试能力，包括建立测试程序，产品标准并验证测试设备

• Provide compliance/quality engineering guidance during product transferring or production line establishment. 产线转移或建立过程中提供合规和质量工程的指导

• Operate inspection procedures 执行测试程序

• Train and qualify LQC 培训及考核LQC

• Set up and follow up the quality plan 建立并跟踪质量计划

  Routine production: 日常生产

• Perform batch record review to develop quality metric and drive defect reduction effort. 实施批记录审阅，建立质量指标并驱动降低不良

• Perform statistical analysis of process data; interpret, compile and organize results. 实施过程数据的统计分析，解析并编辑组织

• Address product quality issues and organize quality improvement 识别质量问题，组织质量改进

• Lead team to complete the NCR/Complaint/CAPA/other quality issues investigation and actions follow up, provide quality engineering guidance to team带领团队完成不合格品/客户投诉/纠正预防及其他质量问题的调查和追踪，给团队提供质量工程的指导。

• Authorize to release in-process product & FG(If they meet the pre-defined spec) relating to his/her responsible product line. 授权放行与其责任产品相关半成品和成品

• Other tasks defined in QMS. QMS 定义的其他职责

JOB QUALIFICATIONS

岗位资质

1.Knowledge / Education 教育背景

• A bachelors degree in scientific or engineering discipline as preferred

本科学历，科学或工程学历优先

• Mechanical or Electrical education background as a plus

机械或电子教育背景优先考虑

2.Job Experience 工作经验

• Minimum 3 years experience in medical device or medicine industry in manufacturing quality assurance. 至少3年医疗器械或医药生产质量保证经验

• Experience in sterile device manufacturing as a plus

无菌器械生产优先考虑

3.Skills / Competencies 技术能力

• Understand requirements of process/equipment validation

了解过程/设备确认

• Understand ISO13485, ISO14971了解13485和14971

• Other regulation requirement as plus. Such as GMP, QSR820 了解其他法规要求，如GMP和QSR820可优先考虑

• Familiar with quality engineering skills, such as finishbone, 5Why, SPC, MSA, DOE, sampling plan, etc.熟悉质量工具，如鱼骨图，5Y，SPC, MSA，抽样方案和DOE等。

4.Credential 证书

• 6 sigma certificate as a plus

具有6 sigma 证书优先考虑

5.Language / Computer 语言/ 计算机能力

• Fluent verbal and written English 流利的读写英语

• Good computer skill of Microsoft application software

计算机操作（微软应用程序）

6.Others 其他

• Good communication skill and team spirit

良好的沟通能力和团体合作精神

• Proactive to complete the work, keep learning in job as plus. 能主动积极的完成工作，具有良好的学习能力者优先考虑。

上班地址：漕河泾出口加工区