Quality Specialist

该职位来源于猎聘 This Position Is Set Up To Take Care Of PMS Related Issues, Such As Complaint Handling, AE Handling, Recall According To Regulation/procedure Requirement; Take Care Of QMS Related Tasks And Other Tasks Assigned By The Line Manager. 该岗位主要负责上市后监管（PMS）相关工作，包括依据法规/程序要求进行投诉、不良事件处理、执行召回；同时负责质量体系（QMS）相关任务以及直线经理交办的其他工作。 1 PMS Related 上市后监管相关

• implemented & improve PMS processes for both local products and imported products； 实施及优化现有进口及国产产品的上市后流程；
• Fulfil the PMS activities timeline requirement from regulation & Corporate； 确保上市后相关活动的工作时限满足法规及总部要求 2 QMS related 质量体系相关
• Document control and support internal and external audit； 文控及支持内外审核；
• All initial supplier/product/customer qualification related tasks, to meet GSP requirement 首营相关工作，满足GSP 要求

3 Other Tasks Per Required 其他任务（根据具体要求） Requirement

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• BS degree or above in the following subjects: Medical Device, Pharmaceutics, Medicine, Chemistry, Biology and any other related subjects
• Very good command of both spoken and written English
• Very good command of MS office"

"1. 2+ Quality experience in MD industry is required.

• Comprehensive knowledge of GSP or GMP, AE reporting/evaluation ,recall and ISO13485 certified auditor is required.
• Experience in PMS management and QMS is preferred. "

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• Excellent communication skills
• Good problem identification and analysis skills"