致力于依据公司内部验证与确认流程以及相关法规/标准对产品进行验证。
Validate products (New or Change) according to validation procedure based on requirements of market regulatory, standards and Group specifications.
业务/职能的范围——主要专业领域/岗位职责
Scope of Business / Function – Key Areas of Expertise /Responsibilities
1. 主导依视路产品进入大中华区市场前的技术合规确认;支持各子公司对外销产品进入国外医疗器械市场前进行相应的法规应对,包含法规识别,注册,技术文档确认,体系协助等。
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.
2. 根据依视路工程项目要求及目标(如自动化、节能项目等),主导对本区域所涉及的依视路蓝标产品及子公司产品进行阶段性的验证与确认;
Lead the validation of the concerned Essilor Blue network products and subsidiaries products to support the Essilor Engineering projects.
3. 5M1E变更管理验证与确认
Lead 5M1E change validation
4. 产品法规/质量技术工具的培训宣传
Provide the product regulatory/quality tools training the Gr. China entities and support its implementation.
5. 向区域市场部提供技术咨询及竞品分析咨询支持
Provide technical consultation and benchmarking consultation to the regional marketing team.
6. 完成职能负责人安排的其它工作
Complete other work assigned by the team leader.
经验 Experience
具3年以上研发/过程质量管理工作经验
Above 3 years of design/process quality experience in industry
熟悉镜片生产制造流程优先
Being familiar with the optical lens manufacturing process is a plus
良好的沟通协调能力及分析能力
Good communication/coordinate and data analytical capability
理工类学历专业背景
Engineering professional background
熟悉镜片的相关国际国家及行业标准及法规:ISO /GB/QB/ANSI
Be familiar with related ISO/GB/QB/ANSI standards of lens industry and regulatory
技能Skills
1. With good oral and written English skill, Chinese is a must
具备良好的英语听说读写技能.中文是基本要求.
2. Open mind / creative / Good communication skill
思维开阔,有创造力.良好的沟通技能
3. Rich and systematical experience on Quality theories and 5 tools.
熟悉质量理论与5大工具
4. National quality engineer certification/6 sigma black belt /reliability engineer certification is preferable.
国家注册质量工程师/6西格玛黑带/注册可靠性工程师优先
5. Project Management experience is preferred
具备项目管理经验的优先