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Quality System Engineer [Job Responsibilities] 1.Establish and maintain the quality management system of Guangzhou company in accordance with the requirements of global medical device laws and regulations and the requirements of the group's quality system architecture按照全球醫(yī)療器械法律法規(guī)要求以及集團(tuán)質(zhì)量體系架構(gòu)要求，建立和維護(hù)廣州公司的質(zhì)量管理體系； 2.Be responsible for tracking relevant laws and standards, and planning and organizing the activities of introducing laws and standards into the quality system; 負(fù)責(zé)跟蹤相關(guān)法規(guī)標(biāo)準(zhǔn)，并策劃、組織開展法規(guī)標(biāo)準(zhǔn)導(dǎo)入質(zhì)量體系的活動(dòng)； 3.Managing preparation, revision, implementation and training of quality system documents管理質(zhì)量體系文件的編寫、修訂、實(shí)施與培訓(xùn)； 4.Manage all kinds of documents and records related to the quality system, control the receiving, distribution, registration and filing of quality documents to ensure that they meet the requirements of the quality system 管理質(zhì)量體系相關(guān)的各類文件記錄，控制質(zhì)量文件的接收、發(fā)放、登記和存檔確保符合質(zhì)量體系要求。 5.Manage quality system documents and product changes to ensure that changes are implemented in accordance with the global change process.管理質(zhì)量體系文件及產(chǎn)品變更，確保變更按全球變更流程執(zhí)行。 6.Organize the internal and external audit of the company's quality management system; promote the closure of audit nonconformities; 組織公司質(zhì)量管理體系內(nèi)審與外審；推進(jìn)審核不符合項(xiàng)的關(guān)閉； 7.Continuously promote quality system improvement activities, such as corrective and preventive measures負(fù)責(zé)持續(xù)推進(jìn)質(zhì)量體系改進(jìn)活動(dòng)，如糾正預(yù)防措施 [Job Requirements] 1. Full-time bachelor’s degree or above, major in bioengineering, medicine, medical device or related. 2. At least 3 years’ experience in quality management in medical devices; experience in CE, FDA and NMPA system inspection. 3. Familiar with ISO13485, medical device manufacturing quality management specification, MDR, FDA QSR 820. 4. Have good communication skills, good oral English skill is an advantage. 5. Strong sense of responsibility and team management ability.