Post Marketing Surveillance 医疗器械质量监管员
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：2016-12-27
- 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：10000-14999/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:
.To support establish & maintenance PMS related SOP, WI and/or system to be consistence with latest regulation and QMS request.
.To responsible for monitoring and follow up of complaint case from China market。
.To maintain the recall system in China Sales and Service Unit, including but not limited to report liability to local FDA authority, follow up of recall/field action status, communication with factories and the closure of recall case.
.To handle the adverse event report system, report the domestic adverse event to local authority; review and check global doubt AE report against local regulation, and responsible for the document submission and final reporting.
.Take the responsibilities of PMS related training to all employees.
.Be coordinator of after-market related quality issue.
.Other duties assigned by department head.
Quality System Duties and Responsibilities:
.Build Quality into all aspects of their work by maintaining compliance to all quality requirements
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:
.To support establish & maintenance PMS related SOP, WI and/or system to be consistence with latest regulation and QMS request.
.To responsible for monitoring and follow up of complaint case from China market。
.To maintain the recall system in China Sales and Service Unit, including but not limited to report liability to local FDA authority, follow up of recall/field action status, communication with factories and the closure of recall case.
.To handle the adverse event report system, report the domestic adverse event to local authority; review and check global doubt AE report against local regulation, and responsible for the document submission and final reporting.
.Take the responsibilities of PMS related training to all employees.
.Be coordinator of after-market related quality issue.
.Other duties assigned by department head.
Quality System Duties and Responsibilities:
.Build Quality into all aspects of their work by maintaining compliance to all quality requirements
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： 质量管理 ISO13485 FDA QSR 820 CFDA GxP
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