上海招聘

Qualification任职资格:

  Bachelor degree or above

  大专或以上学历.

  over 5 years’ experience e as Quality system engineer in manufacturing plant      

  5年以上制造业质量体系工程师经验者优先

  Familiar with ISO9001, ISO14001, ISO13485, 21 CFR 820, 93/42 EEC, SOR98/282-2015, MDSAP, ISO22716 management system and requirement.

  熟悉ISO9001,14001, ISO13485,21 CFR 820 ,93/42 EEC, SOR98/282-2015,MDSAP, ISO22716管理体系及要求

  Be familiar with FDA requirements & ROHS 2.0 standard & Reach standard.

  熟悉FDA要求，熟悉ROHS 2.0标准和Reach标准

  Be familiar with 8D skills, QC 7 tools and MSA, control plan and FMEA

  熟练使用8D技巧、QC7大手法及MSA，控制计划及FMEA等工具

  Good English capability，both oral and written English

   英语流利

            

Responsibilities职责：

  

• To introduce ISO9001, ISO14001,ISO13485,QSR 820, ISO22716, MDSAP management system and ensure it meet requirement

  导入ISO9001, ISO14001,ISO13485,QSR 820, ISO22716, MDSAP管理体系确保符合要求

• Responsible for developing, applying, revising, and maintaining quality standards/procedures/control plan/FMEA to support manufacturing activities.

  负责开发、应用、修改、维护质量标准/程序/控制计划/FMEA以支持生产活动的开展

• Execute ISO9001, ISO14001, ISO13485, QSR 820, ISO22716, MDSAP related job.

  执行ISO9001, ISO14001,ISO13485,QSR 820, ISO22716, MDSAP管理体系的工作

• Make sure ISO9001, ISO14001,ISO13485,QSR 820, ISO22716, MDSAP requirements are implemented correctly and followed strictly

  确保严格执行ISO9001, ISO14001,ISO13485,QSR 820, ISO22716, MDSAP的要求

• Product regulations identification and use it to control product

  产品法规识别并运用到产品上

• To lead internal and external audit for ISO9001, ISO14001,ISO13485,QSR 820, ISO22716, MDSAP and action plan driving for the NCR, follow up the effectiveness of the actions

  指导ISO9001, ISO14001,ISO13485,QSR 820, ISO22716, MDSAP内审和外审及其行动计划，驱动NCR，跟踪整改措施的有效性

• Lead regular internal audit to quality system and push continual improvement

  领导质量体系的常规内审，推动持续改善

• Support manager to organize management review

  支持管理者组织管理评审

• Responsible for CAPA management

  负责公司CAPA管理

• Responsible for KPI management and statistic

  负责公司KPI管理和统计

• Responsible for Quality awareness training for new employees

  负责新员工质量意识培训

• Other tasks assigned by Supervisor

                                               上级安排的其他任务

上海满斡窠达电子科技有限公司成立于2020年04月28日，法定代表人为FITZPATRICK ANTHONY TERENCE。公司总部位于德国，公司已成立近十五年，主要生产手握式按摩仪及高端电子玩具产品。
经营范围如下：
许可项目：第二类医疗器械生产；第三类医疗器械生产；第三类医疗器械经营；货物进出口；技术进出口。
一般项目：技术服务、技术开发、技术咨询、技术交流、技术转让、技术推广（人体干细胞、基因诊断与治疗技术开发和应用除外）；普通货物仓储服务（不含危险化学品等需许可审批的项目）；信息咨询服务（不含许可类信息咨询服务）；社会经济咨询服务（金融信息服务除外）；电子产品销售；日用百货销售；化妆品批发；***类医疗器械销售；家用电器销售；***类医疗器械生产；第二类医疗器械销售；家用电器制造。（除依法须经批准的项目外，凭营业执照依法自主开展经营活动）
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