Job Responsibilities:

• Fully prepare and perform the audit tasks arranged by the company on schedule, urge customers to rectify non-conformities; modify and improve audit materials according to the comments of the reviewers. 充分准备并按期完成公司安排的审核任务，督促客户整改不符合项，根据审核员意见修改完善审核资料
• Complete the technical file assessment task arranged by the company on schedule. 按期完成公司安排的技术档案评估任务
• Timely feedback to relevant personnel on various problems in the work and actively cooperate in solving problems; Understand customer needs and provide feedback to relevant departments during the assigned task handling. 及时向相关人员反馈工作中存在的各种问题，并积极配合解决问题；在分配任务处理过程中，了解客户需求，并向相关部门进行反馈
• Adhere to the audit principle in the audit work, abide by the auditor's code of conduct and the company's regulations, pay attention to your words and deeds, and safeguard the company's interests and image. 在审核工作中坚持审核原则，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
• Timely apply, maintain, and extend own auditor/expert qualification through audit practice, experience exchange, self-study and training regarding regulations, standards and product knowledge. 通过审核项目实践、经验交流、自学以及有关法规、标准和产品知识的培训，及时申请、维护并扩充自身的审核员/专家资格
• Actively participate in the relevant training work arranged by the company. 积极参加公司安排的有关培训工作
• Provide advice on audit-related work and also other work of the company. 提供与审核相关的工作及公司其他各项工作的建议。

Job Requirements:

• Expertise in ISO 13485 and EU CE certification for medical devices. 具备ISO 13485 和 欧盟医疗器械CE认证专业知识
• Familiar with MDD and MDR or IVDD & IVDR. 熟悉MDD & MDR 或 IVDD & IVDR 等法规
• Familiarity with the safety, performance, risk management, sterilization, and biologic evaluation requirements of MDD & MDR or IVDD & IVDR for active medical devices, or non-active medical devices, or in vitro diagnostic medical devices. 熟悉 MDD & MDR 或 IVDD & IVDR 对有源医疗器械、无源医疗器械或体外诊断医疗器械的安全、性能、风险管理、灭菌和生物评估等要求
• At least 4 years full-time work with relevant practical experience in the field of healthcare products, such as medical device or pharmaceutical industry, science, laboratories, notified bodies, examination centers or facilities that test or manufacture medical devices. R&D working experience is preferred. 在医疗保健产品领域，如医疗器械或制药业、科学研究、实验室、公告机构、检查中心或医疗器械测试或生产设施，至少有 4 年全职工作和相关实践经验. 有研发经验优先考虑
• Education Requirements: as a minimum a Bachelor's Degree in 1 or more areas as listed below: a) biology/microbiology; b) chemistry or biochemistry; c) computer and software technology; d) electrical, electronic, mechanical, or bioengineering; e) human physiology; f) medicine; g) pharmacy; h) physics or biophysics; i) material sciences. 学历要求：至少在以下一个或多个领域获得学士学位：a) 生物学/微生物学； b) 化学或生物化学； c) 计算机和软件技术； d) 电气、电子、机械或生物工程； e) 人体生理学； f) 医学； g) 药学； h) 物理或生物物理学； i) 材料科学。
• Good language expression skills, strong English reading and writing skills; Be able to withstand the corresponding work pressure and adapt to frequent business trips. 良好的语言表达能力，英语读写能力强；能承受相应的工作压力，适应频繁出差；
• Good communication skills and team spirit. 具有良好的沟通能力和团队合作精神。