面议
苏州工业园区 | 5年以上经验
发布时间:2018-12-12 11:06:11 | 截止时间:2018-12-20
基本信息:
  • 质量管理/测试工程师(QA/QC工程师)
  • 有经验要求
  • 全职
  • 1
职位描述及要求:
  • 主要工作职责Main responsibilities:
    执行总部相关的产品规范和生产工艺,建立和执行产品试生产和量产的工艺和质量控制计划
    Setup the process engineering& quality control program from product pilot to serial production lots, according to relevant corporate product/process specification, and incoming inspection
    主导完成生产过程验证,测试方法验证和日常质量监测活动
    Carry out the process validation, test method validation & routine quality monitoring program.
    根据总部和当地的质量相关要求,建立合适的生产和质量规范,SOP和在线生产工艺和检测工作指导书
    Establish quality specification, SOP, and, production process engineering& inspection working instruction, with respect to corporate and local quality requirement.
    按照公司内部规范和相关ISO行业标准,建立并执行原材料及产品检测文件。
    Establish and conduct the inspection document for all cleanroom components and product, according to quality requirement and relevant. ISO standard.
    培训和认证在线质量检验人员和生产操作人员的所有质量控制活动. Train and qualify all quality control activities for all the process operators and process inspectors.
    主导执行产品和料件的设计或工艺变更流程,包括和总部和供应商相关流程的设计或工艺变更项目协调。
    Conduct the product/component design or engineering change, including the coordination with supplier and corporate business unit.
    根据放行标准执行物料及在线半成品的放行
    Conduct the release for Incoming material and WIPs based on acceptable criteria.
    产品异常处理和内外客户投诉调查,并应用持续改进工具不断的提高在线产品的质量表现.
    Coordinate the quality nonconformity handling, and internal/external customer complaint investigation. Improve the process and product quality performance level with implementation of continuous improvement tools.
    带领团队进行日常工作并培训辅导下属Implement routine team management and coaching.
    仪器设备校验Equipment calibration management.
    完成部门经理指派的其他工作任务 Implement other tasks as assigned by department manager.

    知识/技能/工作经验Required Knowledge/Skills/Experience:
    教育背景 Education
    本科毕业、理科专业
    Bachelor degree in science or engineering.
    工作经验Experience
    至少五年以上的制造业的质量工程师经历,有欧美企业质量工程师的工作经验
    At least 5 years in quality control experience of manufacturing, if have quality control experience in EU/US company is preferred.
    在医疗设备行业GMP环境下及洁净室运营行业3年以上工作经验
    More than 3 years working experience in GMP environment of medical industry is preferred.
    语言要求Language
    流利的英语口语和良好写作能力,有同国外兄弟公司良好的沟通经验
    Fluent in oral and written English is necessary; good communications skills with international Brother Company.
    技能要求Skills
    熟悉ISO13485, ISO14971, QSR820, GMP验证操作
    Familiar with 13485, ISO14971, QSR820, GMP, validation.
    熟悉质量控制的统计学工具,如GB2828, Minitab, SPC, MSA, GR&R, FEMA, control plan, 等。
    Familiar with quality control statistic tools, such as GB2828, Minitab, SPC, MSA, GR&R, FEMA, control plan.
    DOE prefer
    个人特质/Personal qualities:
    高度的责任感
    Strong sense of ownership
    良好的系统性思维和逻辑性强
    Great systematic and logical thinking.
    优秀的团队合作者,沟通者和协调者
    Team work spirit. Good communication and coordination skills.
    善于自我激励,积极主动,抗压力强
    Self-motivated, initiative and able to work under pressure

岗位条件:
  • 本科
  • 英语 熟练
  • 机械类>机械设计制造及其自动化
  • 不限
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  • 外商独资、外企办事处
  • 医疗设备/器械
  • 100-199
  • 苏州市工业园区方洲路158号
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