深圳相关职位： 市场助理 生物信息副研究员（疾病基因组研究实验室） 生物信息/生物技术副研究员（儿童脑肿瘤方向） 国内高级注册工程师 销售主管（底薪6000元起） 临床工程师（内窥镜） 游戏设计助理 朝九晚六+双休 品牌策划/ 企划专员 医疗器械区域经理/销售经理 校招研发类管理培训生（大健康事业部）
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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无工作经验 -
招1人 -
英语良好 -
11-09 发布
- 五险一金
- 餐饮补贴
- 通讯补贴
- 交通补贴
职位描述
职位描述： Responsibilities:1.Assure factory Quality Systems are compliant to the CE-MDD and FDA Quality System Regulations, GMPs and ISO guidelines.2.Work through all necessary procedures to conduct medical product certifications, with assistance from 3rd party labs and consultants as needed.3.Work with cross-function teams in ensuring products are in compliance with regulatory requirements for specified markets through design, development and manufacturing processes.4.Direct and follow up with manufacturing facilities in establishing, executing, and monitoring strategic and tactical aspects of product compliance and quality programs, to meet the company compliance and quality management system goals.5.Identify top priority compliance and quality issues and develop action plans that support the company business strategy.6.Identify and resolve compliance and quality related issues at the root cause level to prevent problems from re-occurring. Focus on preventive action to minimize resource and schedule impacts.7.Review all projects throughout their life cycle for quality improvement opportunities, risks to quality, and counter measures to quality risks.8.Develop and deploy an executive level summary on compliance and quality program progress.Requirements:1. 3+ years in medical device industry.2. Previous experience with regulatory body (e.g. CE-MDD and FDA) interface is a must.3. Previous experience in either manufacturing operations (OEM) or contracted manufacturing operations (CEM/EMS).4. Extensive current experience, and successful track record as Regulatory Engineer with multi site responsibility5. Strong knowledge of quality management or CE-MDD/FDA management is a must.6. Three years experience in Six Sigma Methodology7. (Statistical process control, Failure Modes & Effects Analysis, Measurement System Analysis, Process Capability Studies, Corrective & Preventive Action, Root Cause Analysis and Risk Analysis)8. Highly motivated individual who can work independently; detail oriented with excellent follow up skills.9. English (reading and writing).简历请发至：recruit@eaglescn.com 职能类别： 医疗器械注册 质量管理/测试工程师(QA/QC工程师) 关键字： 医疗器械 认证 注册
联系方式
深圳市
公司信息
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