杭州招聘

Job Description:
1.质量管理体系的维护和推行，收集现有体系运行不畅之处，主导修订或建立相关流程；
Implement & Maintain Quality System Processes and Procedures
2.应对第三方审核
Coordinator for external audit
3.组织协调内审；
Conduct internal audit 4.CAPA的分析与跟踪，变更流程控制，验证方案和报告的评审
Implement and Maintain an Effective CAPA Process and Change Control procedure. Review validation protocol and report.
5.协调处理投诉，与德国总部进行沟通协调。
Provide QS Systems Support for all Complaint handling activities conducted by Product Line and communicate with HQ
6.质量管理体系相关法规的收集和解读
Collect all Quality System regulation ( not only from CFDA, but also FDA\CE etc).
7.对员工的质量意识、质量法规、体系知识的培训
Be responsible for quality regulation and system training to employees.

Requirements:
Education: Bachelor above with major in biology or medical related major.
医学检验或生物学相关专业，本科以上学历
5 Years of working experiences in quality department, be responsible for quality assurance and quality system at least 3 years in IVD or MD company.
医疗器械行业，5年以上质量管理经验，至少3年以上在质量保证和体系领域工作经验。
Be familiar with ISO 13484 and other regulations or standards from CFDA/FDA/CE
了解ISO 13485质量管理体系以及国内对于医疗器械的法规和标准，CE协调指令以及QSR 820
Good at spoken and written English
英语听说读写流利。
Strong communication and interpersonal skill
良好的沟通和协调能力

EUROIMMUN Medical Laboratory Diagnostics Stock Company was founded in September 1987 and has subsidiaries in nearly 20 countries all over the world with its headquarter in the famous seaside city Lübeck in northern Germany. Currently, there are more than 2,000 employees in the company.

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。