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、临床医学、药理学、生物学、材料学、生物化学等理工科专业；
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、ISO13485和MDSAP法规；
4. 熟悉无源医疗器械的相关标准如ISO 14971，ISO 10993，ISO 11135，ISO 11137等标准；
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的注册审核员资格或者具有灭菌经验或微生物专家优先考虑。
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, medicine, pharmacology, biology, materials science, biochemistry, 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, ISO 13485, and MDSAP regulations;
4. Familiar with related non-active medical device standards such as ISO 14971, ISO 10993, ISO 11135, ISO 11137, 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 or experts with sterilization experience or expertise in microbiology are preferred.