上海招聘

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:
-Responsible for quality document management system establish, maintain and improvement , to ensure compliance status to China regulation and BMX requirements
-Organize and coordinate the assigned work and provide

MAIN ACCOUNTABILITIES:
1.Safety, Health & Environment
-Ensure that all applicable Safety, Health & Environment requirements are compliant to group policy and local legal requirements.
2.QMS Establishment, maintain and improvement
-QMS establishment
-Set up principles and guide team for new QMS establishment
-Maintain document control process, including origin of internal or external, to ensure only valid and current version can be used for production;
-Maintain record control process to ensure a good record practice is implemented within the plant through routine training and monitoring;
3.Audit Program
-Responsible for internal audit implementation to ensure the system is consistenly complying to applicable standards/regulations;.
-Lead and coordinate external audits/inspections external audit/inspection, follow up of all audit related corrective action and make it close on-time.
4.Supplier Management
-Responsible for supplier related quality management including new supplier qualifiaction, existing supplier quality issue handling, supplier audit program implementation and so on.
-Responsible for supplier related change management.
5.Others
-Closely monitor regulation evolvement, implement gap analysis and follow up on mitigation plan implementation
-Implement QMS awareness training plant widely with the support from manager and BioMerieux Corp.

KNOWLEDGE, LANGUAGE AND EXPERIENCE:
1.Bachelor degree (equivalent) or above educational background, majoring in biology, chemistry, medicine or related working experience .
2.Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese.
3.2+ year above similar quality system management experience in Medical Device or Pharmaceutical Industry
4.Familiar with ISO9001& 13485, and other Medical Device or IVD related regulations
5.Skilled with Microsoft Word and Excel
6.Good Interpersonal skill and team player .

生物梅里埃公司创建于1963年，公司依赖自身的科技研究和工业生产资源，始终致力于开发作为医疗和工业用途的体外诊断产品。 集团专门设计、开发、生产和推广应用在临床和工业的系统。生物梅里埃的诊断系统是由试剂、仪器和软件组成，主要是为传染病、工业微生物控制、心血管病和肿瘤病等四个主要策略性领域来设计。
 
在2009年，公司销售额为12亿2千3百万欧元，集团共有17个生产基地和13个研究中心，分布于欧洲、北美洲和南美洲。集团全球拥有39个分公司，至2009年12月31日集团员工超过6,500人。
 
生物梅里埃公司产品有两个应用领域 : 临床和工业，临床市场占总销售额的85%，而工业市场占15%。工业的应用主要在食品、药品和化妆品的微生物分析，增长非常迅速，生物梅里埃是全球体外诊断领域的第八大生产商。

 
生物梅里埃中国有限公司已经20年的发展，自动化微生物鉴定分析系统的用户已达1400余家，自动微生物培养系统已达700余家，全自动细菌计数系统60 余台，手工产品用户覆盖全国的省市70%以上。同时公司拥有数十名微生物临床及工业领域专业人员和工程技术人员，其中许多人员都来自检验一线，拥有丰富的检验经验和仪器维修经验。全面负责生物梅里埃公司产品的销售，仪器的安装、维护及保养，以及用户的培训及技术支持。
 
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