Quality Specialist质量专员(三方合同)
眼力健(上海)医疗器械贸易有限公司
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2019-11-19
- 工作地点:上海-徐汇区
- 招聘人数:1人
- 工作经验:无工作经验
- 学历要求:招1人
- 语言要求:不限
- 职位月薪:6-8千/月
- 职位类别:质量管理/测试工程师(QA/QC工程师)
职位描述
WORKING RELATIONSHIPS
Internal and external contacts.
Internal contacts:
Marketing Team, Sales Team, Supply Chain Team, RA Team
External contacts:
HA, Suppliers and related associations
KEY ACCOUNTABILITIES
Describe in order of relative importance. In listing principal accountabilities emphasize, where appropriate.
List 4 – 10 of the major and result the position is to accomplish. ? Coordination of complaint intake and evaluation, both locally and in cooperation with manufacturing plants for investigations.
? Responsible for Adverse Event reporting activities per local regulation.
? Perform the complaint reporting training when required.
? Draft and update the related quality procedures and perform the quality training per CFDA medical device GSP regulation.
? Be the role of the training coordinator to assign the training in system and follow up the completion of the training; perform the onsite process/procedure training when required.
? Be responsible for the field action or product recall.
? Work with RA to prepare and release the artwork of Chinese labels for imported products.
? Support and oversee the warehouse for incoming medical devices (direct sale business) prior to their release to the Chinese market.
? Identify the current operation process and lead the improvement project.
? Other tasks assigned by manager.
REQUIREMENTS
Skills, education, experience or other qualifications which would be required for anyone who would fill the job. ? Education Requirement: University graduate with background in medical devices, medicine science, chemistry or pharmacy etc.
? Industry experiences: A minimum of two years in the medical device or pharmaceutical industry.
? Position experiences: experience of working in a quality related function. Understanding of complaint management including, performing the complaint investigation and reviewing the complaint for potential reportability.
? Language Skills: English level is at or above CET-6 , skilled in written English.
? Computer Skills: Familiar with the MS software, knowledge of Excel for the data analysis, power point for the monthly presentation, SAP experiences is preferred
? Other Special requirement: Strong in skills for communication with different parties, independent problem solving ability etc.
职能类别:质量管理/测试工程师(QA/QC工程师)
公司介绍
联系方式
- 公司地址:桂箐路65号新研大厦