杭州招聘

1. 负责协助或组织集团质量管理体系的建立、维护及改进

Support or lead establishing, maintanence and improvement of group quality management system

2. 组织并参与生产/经营公司内部及外部审核

Drive and/or involve in internal/external audit of manufacturing companies and trading companies

3. 负责生产/经营公司质量管理体系变更、CAPA、偏差等活动的管理

Responsible for management of change, CAPA, deviation activities etc. in manufacturing companies and trading companies

4. 负责确保生产公司医疗器械/体外诊断试剂生产法规的符合性

Responsible for ensuring ME/IVD regualtion compliance of manufacturing companies

5. 负责组织集团生产/经营公司质量管理体系及法规的相关培训

Responsbible for leading QMS and regulation training in manufacturing companies and trading companies

6. 负责产品说明书及标签的审核管理

Responsible for IFU and lables review

1.生物学、检验学、药学、医学等相关专业学士学位

Bachelar degree in biology, clinical laboratory science, pharmacy, medical science etc

2.ISO 13485内审员

Internal Auditor of ISO 13485

3.3年以上体外诊断试剂/医疗器械质量管理工作经验，外企工作经验优先 

4.熟悉体外诊断试剂/医疗器械生产经营相关要求，熟悉行业法规要求，熟悉质量管理体系管理理念

Skilled with requirements of IVD/MD manufacturing and trading, IVD/MD regulations, concept of quality management system

5.团队合作精神，良好的英语读写能力，良好的沟通能力和学习能力

Team working, good reading and writing of English, good communication and learning skill 

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。