2022-07-04
573次
质量验证工程师
15K-20K/月
年终奖
双休
五险一金
有年假
有补助
旅游
申请职位
基本信息
工作性质全职
招聘人数1人
招聘部门不限
学历要求本科
工作经验不限
年龄要求不限
工作地点丹阳市开发区齐梁路19号丹阳经济开发区科技创业园D2座一楼(江苏省/镇江市/丹阳市)
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职位动态
100%
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0天
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职位描述
Validate products (New or Change) according to validation procedure based on requirements of market regulatory, standards and Group specifications.



- Lead the market release to the Essilor products launched in Gr. China market. Support Gr. China entities handling the compliance topic when they sale medical device product to foreign countries, including identify of regulation, registration, technical document confirmation, etc.

- Lead the validation of the concerned Essilor Blue network products and subsidiaries products to support the Essilor Engineering projects

- Lead 5M1E change validation

- Provide the product regulatory/quality tools training the Gr. China entities and support its implementation

- Provide technical consultation and benchmarking consultation to the regional marketing team

- Complete other work assigned by the team leader





任职要求:

- Above 6 years of quality and RA experience in industry

- Be familiar with the optical lens manufacturing process

- Good communication/coordinate and data analytical capability

- Be familiar with EU/US/China medical device regulation/product quality regulation and ISO13485;QSR 820;China GMP/GSP

- Be familiar the registration requirement and practice on EU MDR/FDA/NMPA

- Be familiar with related ISO/GB/QB/ANSI standards of lens industry and regulatory

- With good oral and written English skill, Chinese is a must

- Open mind / creative / Good communication skill

- Rich and systematical experience on Quality theories and 5 tools

- National quality engineer certification/6 sigma black belt /reliability engineer certification is preferable

- Project Management experience is preferred

- Bachelor degree or above in Engineering
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