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按照全球医疗器械法律法规要求以及集团质量体系架构要求，建立和维护广州公司的质量管理体系；
2.Be responsible for tracking relevant laws and standards, and planning and organizing the activities of introducing laws and standards into the quality system; 负责跟踪相关法规标准，并策划、组织开展法规标准导入质量体系的活动；
3.Managing preparation, revision, implementation and training of quality system documents管理质量体系文件的编写、修订、实施与培训；
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
管理质量体系相关的各类文件记录，控制质量文件的接收、发放、登记和存档确保符合质量体系要求。
5.Manage quality system documents and product changes to ensure that changes are implemented in accordance with the global change process.管理质量体系文件及产品变更，确保变更按全球变更流程执行。
6.Organize the internal and external audit of the company's quality management system; promote the closure of audit nonconformities; 组织公司质量管理体系内审与外审；推进审核不符合项的关闭；
7.Continuously promote quality system improvement activities, such as corrective and preventive measures负责持续推进质量体系改进活动，如纠正预防措施
[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.