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職位描述： Job description: 1、 熟悉或部分熟悉從低風險到高風險醫療器械產品的質量管理流程； Familiar or Partially familiar with the quality assurance process of medical device from Low risk to High Risk; 2、 熟悉生產型企業的內部生產運作流程，能熟練使用各種質量改進的工具與技術進行質量分析； Familiar with production process of manufacturing company, proficient with quality improve tool and quality problem analysis method; 3、 對醫療產品質量管理體系ISO13485, 21 CFR Part 820, MDSAP 質量體系認證有深入的了解，若有ISO13485內審員證書更佳； Familiar with ISo13485，21 CFR Part 820, MDSAP medical device quality standard, qualified ISO13485 internal auditor is better; 4、 具有低風險到高風險醫療器械產品認證及注冊的相關經驗，負責協調和支持相關產品注冊工作,包括但不僅限于：中國NMPA, 美國 FDA，歐洲及其他國際市場以及MDSAP涉及的市場。針對當地法規要求建立和維護相關程序，比如：客戶投訴、上市后監督；產品標識等； Familiar with and have the experience of the NMPA validation and registration of medical device from low risk to high risk, support the registration, including but not limited to NMPA, FDA, CE and other market. Set up the procedure based on the related regulatory requirement, for example, customer complaint, post market monitor, and product label; 5、幫助客戶維護質量體系； To help the customer to maintain the quality system if needed; 6、 幫助客戶協調各部門進行持續質量改進活動； To help the customer to co-operate with each functions to do quality improvement; 7、 幫助客戶參與風險管理活動； To help customer to participate in risk management; 8、幫助客戶組織公司員工GMP知識方面的培訓以及相關SOP的培訓； To help customer to carry on GMP and other SOP training. 任職資格： Requirements: 1、 生物醫藥或醫療器械等相關專業，本科或以上學歷； bachelor degree or above of biological medicine or medical device; 2、 2-3年以上醫藥或醫療器械企業質量體系管理工作經驗或相關咨詢公司的經驗； more than 3 years’ working experience in QA or QC in Medical device or Pharmaceutical industry or relevant MD/IVD consulting Company 3、 熟悉醫療器械質量管理的法律法規； Be familiar with medical device supervision regulation 4、 能編制質量管理體系文件，有內審員資格證書更佳； Ability to set up the quality system, has internal auditor certificate is better; 5、 熟悉ISO13485，ISO14971，GMP等質量管理體系標準； Be familiar with ISO13485, ISO14971, GMP quality management system 6、 能熟練應用計算機進行質量統計，對工序及產品質量進行統計完成報告書； Proficient in MS Office SWs (Word, Excel, PPT, Project etc). 7、 有英文水平； English in listening, speaking, reading and writing 8、 工作認真嚴謹，具有溝通、協調、組織管理能力和解決問題的能力； Be strong and effective communicator with Corporate, and work under pressure, as well with the frequent trip with daily work. 9、具備高度的質量意識和工作責任心，良好團隊合作精神，并能承受工作壓力，并能接受現場審核出差需求。