质量专员Quality Specialist
迈柯唯（上海）医疗设备有限公司
- 公司规模：150-500人
- 公司性质：外资(非欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2016-09-05
- 工作地点：上海-长宁区
- 招聘人数：若干人
- 工作经验：5-7年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：15000-19999/月
- 职位类别：医疗器械生产/质量管理
职位描述
职位描述：
Main responsibilities:
. Regulatory and qualification controlling on new product, vendor and customer in quality system;
. Guide and supervise on product purchasing, incoming goods, maintain the goods, sales, return , non-conformity product management, transportation, CFDA product tracebility system report etc. ;
. Responsible for issuing standard of product Chinese label and registration statement for Chinese IFU, communication with factory to ensure the compliance with regulations.
. Check the promotion material to ensure the compliance with regulations.
. Assist to establish the Quality system based on CFDA GxP and ISO13485, perform the internal audit and CAPA follow up.
. Conduct quality training to enhance the regulatory compliance in organization.
Required Knowledge/Skills/Experience:
. Bachelor’s degree on subjects of Medical device/life science/chemistry or other relevant science
. Minimum 5 years related experience in medical device/pharmacy related quality management, manufacturing or auditor role.
. Previous background and experience in quality management or auditing activities
. Strong knowledge and experience in ISO13485, FDA QSR 820, CFDA GxP related regulations.
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Main responsibilities:
. Regulatory and qualification controlling on new product, vendor and customer in quality system;
. Guide and supervise on product purchasing, incoming goods, maintain the goods, sales, return , non-conformity product management, transportation, CFDA product tracebility system report etc. ;
. Responsible for issuing standard of product Chinese label and registration statement for Chinese IFU, communication with factory to ensure the compliance with regulations.
. Check the promotion material to ensure the compliance with regulations.
. Assist to establish the Quality system based on CFDA GxP and ISO13485, perform the internal audit and CAPA follow up.
. Conduct quality training to enhance the regulatory compliance in organization.
Required Knowledge/Skills/Experience:
. Bachelor’s degree on subjects of Medical device/life science/chemistry or other relevant science
. Minimum 5 years related experience in medical device/pharmacy related quality management, manufacturing or auditor role.
. Previous background and experience in quality management or auditing activities
. Strong knowledge and experience in ISO13485, FDA QSR 820, CFDA GxP related regulations.
职能类别： 医疗器械生产/质量管理
关键字： CFDA GxP ISO13485 FDA QSR 820
公司介绍
MAQUET是全球领先的手术室、ICU医疗工程和设备供应商之一，隶属瑞典GETINGE公司医疗系统集团。总部位于德国原始黑森林边的拉施塔特。下属外科系统/感染控制部、心脏外科部、重症系统部，所辖品牌均为行业内领先者，原MAQUET，ALM，HANAU，JOSTRA，SIEMENS（呼吸、麻醉）等。
迈柯唯（上海）医疗设备有限公司是MAQUET在中国设立的全资子公司，为中国医院的手术室、心胸外科、ICU提供最具品质系统工程和系列产品，并以最优质的、快速的服务立足于中国市场。
迈柯唯（上海）医疗设备有限公司
人力资源部（邮件主题请注明应聘职位）
https://career012.successfactors.eu/career?company=GetingeProd
迈柯唯（上海）医疗设备有限公司是MAQUET在中国设立的全资子公司，为中国医院的手术室、心胸外科、ICU提供最具品质系统工程和系列产品，并以最优质的、快速的服务立足于中国市场。
迈柯唯（上海）医疗设备有限公司
人力资源部（邮件主题请注明应聘职位）
https://career012.successfactors.eu/career?company=GetingeProd
联系方式
- Email：hr.china@getinge.com
- 公司地址：地址：span上海市长宁区红宝石路188号1幢古北SOHO 20楼