Job Descriptions:
1．Implement and execute audit tasks assigned by the company related to active medical devices and standalone software/AI software products. Stay updated with the latest technological developments and regulatory updates to meet the technical review requirements；
贯彻执行公司安排的与有源医疗器械以及软件/独立软件相关产品的审核任务，学习跟踪***发展以及法规更新，满足技术评审要求；
2. Provide timely feedback to relevant personnel on various issues encountered during the audit process and actively cooperate to resolve problems. Understand customer needs during the audit and communicate them to relevant personnel and departments；
在评审过程中及时向相关人员反馈审核工作中出现的各种问题，并积极配合解决问题；在审核中了解客户需求并向相关人员和部门反馈；
3. Adhere to the principles of fairness and impartiality in audits, comply with the auditor's code of conduct and company regulations, be mindful of one's words and actions, and safeguard the company's interests and image；
在审核工作中坚持审核公平公正原则，遵守审核员的行为规范和公司的各项规定，注意自己的言行，维护公司利益和形象；
4. Complete the preparation of audit materials promptly, communicate with customers before the audit, urge customers to rectify non-conformities (if any) after the audit, and modify and improve audit materials according to the opinions of the Certification Department.
及时完成审核资料的准备，并在审核前与客户进行沟通，审核结束后督促客户整改不符合项（若有时），根据发证部发证的意见修改和完善审核资料；
5. Timely complete the review work of CE technical documents assigned by the company;
及时完成公司安排的CE技术文件的评审工作；
6. Actively participate in relevant training arranged by the company;
积极参加公司安排的有关培训工作；
7. Provide suggestions related to audit work and other company tasks.
提供与审核相关的工作及公司其他各项工作的建议。

Job Requirements:
1. Master's degree or above in related fields such as computer science, software engineering, algorithm engineering, artificial intelligence and machine learning, automation, etc.
硕士及以上学历，计算机，软件工程、算法工程，人工智能与机器学习，自动化等相关专业；
2. More than four years of experience in medical device manufacturing companies;
有四年以上医疗器械生产企业经验；
3. Primarily engaged in product design, development, quality inspection, quality management, or regulatory affairs. Candidates with experience in active medical device software development are preferred;
主要从事于产品设计、开发，质量检验，质量管理或法规事务等方面工作；具有有源医疗器械软件开发相关经验的人员优先；
4. Good team cooperation and customer service spirit;
良好的团队合作及客户服务精神；
5. Good proficiency in listening, speaking, reading, and writing in English, reaching at least CET 6 level;
良好的英语听、说、读、写能力，达到CET 6级水平；
6. Basic computer operation skills (e.g., MS Office, Lotus Notes, SAP);
有基本的计算机操作能力（例：MS Office, Lotus Notes, SAP)；
7. Proactive spirit and the ability to withstand work pressure, with frequent business trips being required;
具有主动精神并能够承受工作压力，可经常出差。