85 Assist into manage the system (such as ISO 13485, ISO14000, BSCI, chemical management system ) to ensure the system is effective and maintained;
协助管理体系（如ISO 13485,ISO14000, BSCI,化学物质管理体系），确保体系的有效运行及保持；
85 Responsible for the development of quality system document, including writing and revision of corresponding documents, and supervise the implementation to ensure document used in the company is effective and correctness;
负责制定质量体系文件，包括文档的编写、修订等工作，并督导实施以确保在公司范围内所使用文件的有效性和正确性；
85 Assist each departments of the company to establish, improve and optimize the processes and management specifications, and be responsible for monitoring the effectiveness of the operation of quality system for each department;
协助公司各部门建立、改进和优化各项业务流程和管理规范，负责对各个部门体系运行的有效性进行监控；
85 Planning, preparation and organization of various quality activities such as internal audit and management review to make sure the system is effective and reliable; Assisting in the organization and coordination of external audit, such as audits of authorities, third party and customers; Follow up the audit corrective actions to ensure the action are implemented;
内部审核、管理评审等各类质量活动的策划、准备和组织实施，确保管理体系有效性和可靠性；协助外审工作的组织与协调，例如政府部门、第三方、客户等审核；负责跟进审核相关的纠正措施确保措施得到落实；
85 Responsible for the investigation of leading quality accidents and tracking and closing of corrective and preventive measures;
负责主导质量事故的调查，以及纠正预防措施的跟踪关闭；
85 Establish and improve internal and external quality information feedback and processing systems, strictly settle the inconsistencies with quality system standards and control of nonconforming products;
建立和健全内外部质量信息反馈和处理系统，严格处理与质量体系标准不一致事项和不合格品的控制；
85 Provide training relating to QA system to employees in order to improve their quality concept.
为员工提供有关质量保证体系的培训提高其质量意识。
85 Continuous improvement of the company's system through continuous implementation of process optimization;
通过不断实施的流程优化，使公司体系持续改进；
85 Planning, preparation and organization of other quality management activities;
其它质量管理活动的策划、准备和组织实施；
85 Take additional assignment upon request
执行完成上级交给的其他临时性工作。
任职要求：
85 Bachelor degree or above; Engineering background；
本科或以上学历；工科毕业；
85 Have comprehensive quality management knowledge, be familiar with medical device quality management system and related policies, regulations and standards, and be familiar with medical device products is preferred;
具有全面质量管理知识，熟悉医疗器械质量管理体系及相关政策、法规和标准，熟悉医疗器械产品优先；
85 3 years and above of the quality system work experience of manufacturing medical device companies, with ISO 13485 internal auditor qualification certificate, engaged in internal audit, management review and other related quality management activities planning and organization experiences;
3年或以上生产型医疗器械企业的质量体系工作经验，具有ISO 13485内审员资格证，从事过内部审核、管理评审等相关质量管理活动的策划和组织；
85 Strong quality planning and data analysis capabilities, and successful quality improvement experience;
具有较强的质量策划和数据分析能力，有成功的质量改进经验；
85 Familiar with computers and common office software, with the ability to communicate in English at a level sufficient to handle foreign audits independently.
熟悉计算机及常用办公软件，具有独立应对国外审核的英语水平；
85 Strong written editorial skills, communication skills, organizational skills, coordination skills, and good teamwork spirit;
有较强的文字编辑能力、沟通能力、组织能力、协调能力，良好的团队合作精神；
85 Familiar with ISO14001 environmental management 、 BSCI social responsibility system and chemical management system, can apply the system to practical work;
熟悉ISO14001环境管理和BSCI社会责任等体系以及化学物质管理体系，能将体系运用到实际工作中；