南京 [切换城市] 南京招聘南京生物/制药/医疗器械招聘南京药品生产/质量管理招聘

质量经理 Quality Manager

欧蒙医学诊断(中国)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2020-12-28
  • 工作地点:北京
  • 招聘人数:1人
  • 工作经验:10年以上经验
  • 学历要求:本科
  • 语言要求:英语熟练
  • 职位月薪:2.5-4万/月
  • 职位类别:医疗器械生产/质量管理  药品生产/质量管理

职位描述

1.Follow up regulatory tendency, planning optimal proposal to compliance with regulatory, including QMS and product regsitraiotn process.
紧跟全球法规趋势,制定合理化合规方案,确保从质量体系建设,产品注册过程的全过程合规性。
2.Get registraiotn licesne according to yearly registration plan.
根据公司计划,完成注册任务,包含临床任务。
3.To set up, impromove QMS for EIAG, to ensure all comopanies to apply and get/keep all license.
全面建设,推进并持续改进集团的质量管理体系,确保公司在规定时间内体系运行正常。
4.Coach and develop team member.
部门工作指导安排,部门人员培养。

任职要求:

1.Bachelor's Degree or above of Medical/Biological related major.
医学/生物学相关专业本科及以上学历。
2.Minimum of 10 years experiences with regulatory of Medical Devices/IVD.More than 5 years managerial experience
至少10年以上医疗器械/体外诊断试剂领域法规类工作经验;5年以上管理经验
3.Understand well of global regulatory of medical device, including QMS and registraiton requirements. Visibility of the larger picture.Internal auditor of ISO 13485
对全球法规全面了解,包括注册和质量体系相关的标准。具有全局观和内审员证书
4. Fluent oral and Writing English; Good at communication;Good management skill
熟练的英语阅读和写作能力;良好的沟通能力;良好的管理能力。

公司介绍

EUROIMMUN was founded in September 1987 and today has its headquarters in Lübeck, Germany. EUROIMMUN produces reagents for medical laboratory diagnostics. In the foreground are test systems for the determination of various antibodies in patient serum in the diagnosis of autoimmune diseases, infectious diseases and allergies. The company is based on worldwide-patented state-of-the-art production methods and microanalysis techniques and is one of the world's leading manu¬facturers of medical laboratory diagnostics. The company’s reference laboratory is unequalled in the whole field of autoimmune diagnostics. It helps EUROIMMUN customers to secure their results. With their quality and standardization, EUROIMMUN products are capturing the leading position in the world.
EUROIMMUN embarked China in 1999. The Beijing office has now become the headquarters of EUROIMMUN Asia Pacific. The company sets high-standard research and production base in China and Singapore. Its sales teams cover most Asia-Pacific countries and regions such as China’s mainland, ChinaHong Kong, ChinaTaiwan, South Korea, Singapore and Thailand. With numerous global patents, state-of-the-art technology and clinical diagnostics techniques, the company wins high recognition from here and has become the leader of Asian market.

欧蒙医学实验诊断股份公司由德国吕贝克大学病理学教授Winfried Stöcker博士创建于1987年,是世界领先的医学诊断试剂及自动化仪器研发与生产的跨国企业。逾两千名员工服务于全球近200个国家及地区,其产品和服务惠及世界五大洲数万间实验室。欧蒙集团在自身免疫性疾病、感染性疾病、变态反应性疾病诊断领域拥有领先的诊断方案,在分子诊断及抗原检测等领域拥有先进的技术。同时,专业的欧蒙参考实验室为全球用户提供疑难样本的诊断和验证服务,由德国DAP(德国实验室认证机构)认证的欧蒙全球质量评价项目为广大客户提供全球实验室质量交流平台,助力客户加强实验室质量管理。
欧蒙医学诊断(中国)有限公司于1999年成立于北京,是欧蒙亚太集团总部。公司在中国、新加坡建立有先进的产品研发和生产基地,专业技术团队遍及中国各省市、中国香港、中国台湾、韩国、新加坡、泰国等亚太国家及地区。凭借提供高品质、全方位的医学诊断方案,秉承科技创新造就卓越品质,欧蒙诊断促进人类健康的企业宗旨,欧蒙的技术、产品与服务赢得了亚太地区客户的高度认可与信赖,成为医学诊断市场的领导者。

联系方式

  • Email:hr@oumeng.com.cn
  • 公司地址:北京市朝阳区北辰东路8号北辰时代大厦