职位描述：
1. 根据ISO 13485标准、EU法规和MDSAP法规以及公司内部程序和要求，高效地执行审核任务；
2. 按照审核流程要求，撰写详尽的审核报告，出具审核过程中发现问题的不合格报告和改进建议；
3. 按照欧盟法规要求，对制造商提交的技术文件进行及时的合规性评审；
4. 根据客户需求，策划和提供专业技术交流会和研讨会，以为客户提供有价值的技术支持；
5. 持续关注并学习医疗器械领域的最新法规、认证和评审流程；
6. 积极参与授权的培训课程和交流会议，持续提升个人专业能力和知识水平。
职位要求：
1. 大学本科及以上学历，生物医学工程、医疗器械、电子/通信工程、光电、自动化、测量技术与仪器、微电子、人工智能、计算机软件等理工科专业；
2. 具有4年及以上医疗器械相关领域的工作经验（研发，测试验证，质量控制，法规注册等），至少2年及以上的医疗器械的质量管理工作经验；
3. 熟悉欧盟医疗器械法规(MDR&IVDR)，ISO13485和MDSAP 法规；
4. 熟悉有源医疗器械的相关标准如IEC60601，IEC 62304，ISO 14971等；
5. 英语听说读写熟练，能撰写英文报告；
6. 积极的工作态度，具备独立工作和面对困境的能力，能适应出差；
7. 愿意持续学习，具备良好的沟通能力和团队协作精神；
8. 具有CCAA的注册审核员资格者优先考虑。
Job Description:
1. Conduct audit tasks efficiently in accordance with the ISO 13485, EU regulations, MDSAP regulations, and the company's internal procedures and instructions.
2. Write audit reports according to the audit process requirements, issue deficiency reports for findings during the audit, and provide suggestions for improvement.
3. Perform timely compliance reviews on technical documents submitted by manufacturers in accordance with EU regulatory requirements.
4. Plan and provide professional technical exchanges and seminars based on customer needs to provide valuable technical support.
5. Continuously learn about the latest regulations, certifications, and review processes in the field of medical devices.
6. Actively participate in authorized training courses and exchange meetings to continuously improve personal professional skills and knowledge level.
Requirements:
1. Bachelor's degree or above in biomedical engineering, medical device, electronic/telecommunications Engineering, photoelectric, automation, measurement technology and instruments, artificial intelligence, computer software, or other related fields of science and engineering.
2. Own at least 4 years of work experience in the field of medical devices (including R&D, testing and validation, quality control, regulatory/registration, etc.), and with at least 2 years of experience in quality management of medical devices.
3. Familiar with EU medical device regulations including MDR and IVDR, and ISO 13485 and MDSAP regulations.
4. Familiar with related medical device standards such as IEC60601, IEC 62304, ISO 14971, etc.
5. Proficient in English listening, speaking, reading, and writing, capable of writing reports in English.
6. Have a positive work attitude, the ability to work independently and face challenges, and be willing to travel.
7. Willing to continue learning, with good communication skills and a team spirit.
8. CCAA registered auditor is preferred.