职位概述
This position is responsible for conducting audit/technical documentation review in Active Medical Product (AMP). For the purpose of international medical device regulatory approval.
该职位的主要职责是在大中国区范围内针对有源医疗器械产品进行审核和技术文件评审工作，以满足有源医疗器械制造商的国际市场准入要求。
岗位职责
1. Conduct auditing/technical documentation review according to standard requirements, regulatory requirements, procedures and code of conduct;
按照标准、法规、程序及行为准则实施现场审核及技术文件评审
2. Maintain customer communication as project leader for the allocated customers regarding auditing and certification.
作为项目主管，就审核、认证方面的要求和客户进行技术交流
3. Support relevant in AMP field for customer service, increase customer satisfaction;
支持有源医疗器械相关的客户服务，提升客户满意度；
4. Know well about all policy of T05V S05D , procedures related to medical device business, with qualification as medical device in certain area;
充分理解TUV南德和医疗器械业务相关的正常、流程，保持医疗器械相关领域的审核资质；
5. Maintain and develop skills in the field of standard, regulation, medical device (e.g. familiar with the product knowledge and standard requirements, follow the latest standard and regulation).
保持和提升在标准、法规、医疗器械产品方面的技能（例如：熟悉专业领域的产品知识及标准要求、跟踪标准法规的最新动态）
任职条件
1. At least bachelor degree with diploma in active medical device related major (e.g. Biomedical Engineering, Electronic Engineering, Automatic Control);
本科及以上学历，有源医疗器械相关专业（例如，生物医学工程，电子工程，自动控制）；
2. At least 3 years working experience in the field of active medical device;
3年及以上有源医疗器械相关工作经验；
3. At least 2 years quality management working experience(e.g. manufacturing, quality control, or research);
2年及以上质量管理工作经验（例如，生产、质量控制、研发）；
4. Diligence, self-motivation, self-improvement and strong teamwork spirit;
具有勤奋、主动、自我改进以及充分的团队合作精神；
5. Good communication and interpersonal skills;
具有良好的沟通和人际交往能力；
6. Can work independently and efficiently, can work under pressure;
能够独立、有效工作，能承受压力；
7. Good computer skill;
具有良好的电脑操作技能；
8. Good command of English;
具有良好的英语能力；
9. Physical condition allows normal working, stable outputs and business trip as required.
身体条件允许正常稳定的工作、能适应出差；
10.CCAA qualification is preferable
具有CCAA注册审核员资格优先；
11.Work experience with medical device standards/regulation (e.g.ISO 13485, ISO 14971, IEC 60601-1, MDD or MDR) is preferable
具有医疗器械标准法规经验（例如，ISO 13485, ISO 14971, IEC 60601-1, MDD 或 MDR）优先。