无源医疗器械审核员（ 医疗健康服务部）-天津-03398 天津

月薪：

该公司所有职位
  • 5-7年经验
  • 招1人
  • 英语熟练
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 定期体检
  • 员工旅游

职位描述

职位描述： Job Responsibilities1.Perform Non-active medical device audit according to standard requirements, regulatory requirements, internal requirements; Focus on EU mandatory market approval (CE mark) and other applicable international multi-agreement approval, including: -European Medical Device Directives (MDD); -Canadian Medical Device Regulations (CMDR); -Japanese Pharmaceutical Affairs Law (JPAL); -International quality system standards (e.g. ISO 13485&ISO 9001);-as well as internal Notified Body and TüV SüD America criteria including all related tasks, such as planning, -- reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body;2.Perform evaluations of regulatory submissions including: Technical File Review (EU MDD/93/42EEC Directives);3.Bring in potential customer information;4.Support sales and marketing non-activities in technical issues;5.Perform other duties assigned by Deputy Manager / Department Manager.Job Requirement1.Bachelor degree or above in scientific field (Microbiological, pharmaceutical, organic and inorganic material, machining, chemical etc). 2.Minimum 5 years working experience in the fields of medical device design, quality control, regulatory clinical, project management and manufacturing;3.Ideally minimum 2 years working experience in quality system management;4.Authorized auditor is a best (CCAA 9001 authorized auditor)5.Good understanding and fulfillment to working related targets, standards, policies, procedures and instructions; 6.Respect and safeguard company’s image, reputation and benefit;7.Diligence, self-motivation, self-improvement and strong teamwork spirit;8.Good communication and interpersonal skills;9.Can work independently and efficiently; can work under pressure;10.Good computer skill;11.Good command of English (Written-fluent, oral-medium);12.Physical condition allows normal working, stable outputs and frequent business trip as required. 职能类别： 医疗器械生产/质量管理

联系方式

和平区南京路189号津汇广场

公司信息

成立于1866年，总部位于德国慕尼黑，TüV南德意志集团是世界领先的技术服务公司。 如今，我们在全球拥有22,000多名员工遍及全球的800多个办事处。我们的专家热衷于技术追求并时刻帮您挖掘商业机会。在信念--“技术是为了创造更好生活”支撑下，我们与客户精诚合作，着力为您实现运作优化，进入国际化市场、强化市场竞争力。 TüV南德意志大中华集团总部设在上海，主要分公司及办事处分布在北京、广州、深圳、香港、台北以及约40个分支机构贯穿整个区域，TüV南德意志集团是国际贸易合作的重要支持桥梁。2,000多名专注于各个领域的专家和训练有素的工作人员向客户提供支持，致力于新产品的推广，服务和体系为全球所接受。迄今为止，TüV南德意志集团已与约20,000家公司有过合作，包括政府机构、小型企业和知名的大公司。我们持续地发展与创新，顺应客户要求不断扩大我们的服务范围。

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企业入驻日期： 2017-11-09

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