上海招聘

1. Report to: Quality Manager

  向质量经理汇报

2．Qualification

任职资格 

l Excellent logical thinking

  良好的逻辑思维

  l Good communication skills and training skills.

  良好的沟通及培训能力

  l Good operation skills of MS-Office

  熟练使用办公软件

  l Good English capability

  英语流利

l over 3 years Medical Device experience as Quality system engineer in manufacturing plant

3年以上医疗制造业质量体系工程师经验者优先

l Familiar with ISO9001, ISO14001, ISO13485, 21 CFR 820, SOR98/282-2015 management system, 93-42 EEC medical device directive.

熟悉ISO9001/14001/ ISO13485/ 21 CFR 820 / SOR98/282-2015管理体系, 93-42 EEC医疗器械指令。

l Be familiar with FDA requirements & ROHS 2.0 standard

熟悉FDA要求，熟悉ROHS 2.0标准

l 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

l 2 years’ Experience in GMP or ISO13485/MDSAP medical quality system 

2年以上GMP或ISO13485医疗器械质量体系背景

l ISO13485 internal auditor certificate needed

有ISO13485内审员资格

l Bachelor or above degree in science and engineering

  大专或以上工科类专业

 

3. Responsibilities:

职责：  

l To maintain ISO13485 /MDSAP quality system and ensure it meet FDA requirement

维护ISO13485/MDSAP质量体系确保符合FDA的要求

  l 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

l Execute ISO 14001 related job.

执行ISO14001环境体系的工作

l Making sure the GMP and ISO13485 requirements are implemented correctly and followed strictly 

确保严格执行GMP和ISO13485的要求 

l Product regulations identification 

产品法规识别

l To lead internal and external audit for ISO13485 & 9001 and action plan driving for the NCR, follow up the effectiveness of the actions

指导内审和外审及其行动计划，驱动NCR，跟踪整改措施的有效性

l 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 

l Support manager to organize management review

支持管理者组织管理评审

l Other task assigned by Supervisor

上级安排的其他任务

Remark: short time contract is around 3~12months

备注：短期合同（3到12个月）

上海烨智电子科技有限公司是一家为全球奢侈品牌提供优质产品和服务的供应商和制造商，2018年成立于上海市金山区亭林，主要经营研发、组装、生产：电子塑料玩具、振动按摩器、洁面仪、牙刷、按摩油、按摩蜡烛、按摩饼、服装、LED展示架、LED展示牌及其他配饰，销售本公司自产产品并提供售后服务。我们旨在为客户提供优质产品及服务，恪守承诺，谋求长远发展，体验前所未有的革新，带领赛文团队达成客户满意，为员工创造更美好的生活。
VIS Shanghai judged as a manufacturer and supplier of superior quality products and services for the world's top luxury brands-FOREO. Founded in Shanghai JinShan in 2018, VIS is primarily engaged in research, development, assembly and production: electronic plastic toys, hand-held facial cleaners and massagers, cosmetics, electric toothbrushes, massage oils and massage candles, cakes, clothing, LED display, LED displays, and other accessories. Our aim is to provide high-quality products and services to our customers, honor our commitments, seek long-term development, experience unprecedented innovation and guide our VIS team in satisfying our customers and creating a better life for our employees.