质量工程师 Quality Engineer
欧蒙(杭州)医学实验诊断有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械 制药/生物工程
职位信息
- 发布日期:2014-05-05
- 工作地点:杭州
- 招聘人数:1
- 工作经验:二年以上
- 学历要求:本科
- 语言要求:英语
- 职位类别:质量管理/测试工程师(QA/QC工程师) 药品生产/质量管理
职位描述
岗位职责:
1.负责协助直接主管建立和完善公司质量管理体系
Assist direct supervisor to improve and maitainence QMS.
2.负责协调质量管理体系文件的编制、修订、审核、培训和实施,确保质量管理体系的有效性
Be responsible for coodinating the drawing & revision & audition & training & implementation of all documents to ensure the efficient of QMS.
3.负责组织完成公司质量体系的年度审核和管理评审,并撰写审核报告
Be in charge of organizing of internal audit and management review and drawing up the audit report.
4.负责质量体系认证工作
Responsbile for the QMS authentication.
5.负责公司现场质量管理,对存在的质量问题制订纠正和预防措施并组织实施
Be responsible for on-site quality assurance. Organize the execution of corrective and preventive measuares.
6.负责收集和分析质量信息
Collect and analyze qulaity-related infromation.
7.完成领导交办的其他工作
Other duties as requested or assigned.
具体要求:
1.生物相关质量管理专业本科学历
Bachelor’s degree in biological science with an emphasis in quality.
2.至少有3年IVD/MD/药品生产相关行业质量管理的经验
At least three years of experience in quality management at a IVD/MD/pharmaceutical manufacturing related fields.
3.熟悉IVD/MD相关标准和法规
Well-known IVD/MD related regulations and standards。
4.工作主动,责任心强,良好的团队合作精神
Strong sense of responsibility, work actively and positively, as well as good team work spirit.
5.优秀的沟通协调和解决问题的能力
Good skills in communication negotiation and problem solving.
6.英语听、说、写良好
Good writing/reading/speaking English skills
公司介绍
EUROIMMUN is the advanced diagnostic reagent and automated Instrument manufacturer. 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. Based on worldwide-patented state-of-the-art production methods and microanalysis techniques, EUROIMMUN is one of the world leading manufacturers of medical laboratory diagnostics. EUROIMMUN products can be found in nearly hundred countries and regions worldwide, its products and services are employed in over ten thousand laboratories around the world.
EUROIMMUN entered China market in 1999 and established EUROIMMUN Beijing and EUROIMMUN Hangzhou successively. As a wholly owned subsidiary of EUROIMMUN, EUROIMMUN China is responsible for production, sale, R&D and service of EUROIMMUN products.
Since EUROIMMUN China was founded over ten years ago, it has been the guide of autoimmunity, the pioneer of standardization, the promoter of the total laboratory solution and the leader of china diagnostics.
In China, EUROIMMUN products are employed in more than 90% hospitals. EUROIMMUN co-laboratories and demonstration laboratories can be found in nearly 100% key hospitals.
欧蒙医学实验诊断股份公司(下简称“欧蒙”) 始创于1987年,全球总部位于德国北部欧洲著名的海滨胜地吕贝克(Lübeck),分公司遍布全球近20个国家的主要城市,现有在职员工近2000人。
欧蒙是世界领先的医学实验诊断试剂及自动化仪器的研发与生产企业,除在自身免疫性疾病、感染性疾病和变态反应性疾病诊断领域拥有先进的检测产品和技术外,凭借着拥有全球专利的先进生产工艺和微观检测技术,欧蒙已发展成为世界一流的医学实验诊断设备制造商。此外,欧蒙还致力于实验室全套解决方案的研究与发展,开发了一系列高水平的实验室自动化仪器与软件系统。迄今,欧蒙的产品和服务已遍布世界五大洲、近百个国家和地区的数万间实验室。
欧蒙于1999年进入中国市场,先后创建了欧蒙(北京)医学诊断技术有限公司和欧蒙(杭州)医学实验诊断有限公司(以下统称“欧蒙中国”)。欧蒙中国作为德国欧蒙医学实验诊断股份公司在中国的全资子公司,是集研发、生产、销售、市场、服务为一体的综合性企业,其总部设立于北京。
进入中国十余年来,欧蒙中国借助自身的产品和研发优势,已建立起完善的产品体系,形成了“研究、生产、学习”相结合的综合发展模式,并以先进的诊断技术、优质的检测产品和服务赢得了广大客户的信赖。
欧蒙中国已成为中国自身免疫事业的引导者,标准规范化试剂的倡导者,实验室解决方案的推行者以及医学诊断行业的领军者。在中国,超过90%的检验单位正在使用欧蒙的产品;几乎100%的全国重点实验室与欧蒙中国开展示范合作,共建联合实验室。