IVD体外诊断审核员

职位描述：

1. 根据ISO 13485标准、EU IVD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IVDR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，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.拥有医学、生物工程、质量管理或相关专业本科及以上学历，具备4年以上医疗器械审核、质量管理或相关领域的工作经验，熟悉ISO 13485、EU IVD/IVDR、MDSAP等法规者优先；

2. 深入理解医疗器械行业法规和标准，包括质量管理体系、风险管理、文件控制等；

3. 具备优秀的分析能力和问题解决能力，能够独立完成审核报告，提出改进建议；

4.具备良好的沟通技巧和团队协作精神，能够与客户、供应商及内部团队有效沟通；

5. 良好的英文阅读和写作能力，以便处理国际项目；

6.具备良好的职业道德和责任心，能够承受工作压力，适应出差需求。

Job Description：

1. Conduct audit tasks efficiently in accordance with the ISO 13485, EU IVDR, MDSAP regulations, and the company's internal procedures and instructions.

2. Write audit reports according to the audit process requirements, issue deficiency report for the findings and suggestions for improvement during the auditing process.

3. Perform timely compliance reviews on technical documents submitted by manufacturers in accordance with EU IVDR.

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 authorization training courses and exchange meetings to continuously improve personal professional skills and knowledge level.

Job Requirements:

1.Bachelor’s degree or above in medicine, biomedical engineering, quality management, or related fields, with at least 4 years of experience in medical device auditing, quality management, or related areas. Familiarity with ISO 13485, EU IVD/IVDR, MDSAP, and other regulations is preferred;

2.In-depth understanding of medical device industry regulations and standards, including quality management systems, risk management, and document control;

3.Strong analytical and problem-solving skills, with the ability to independently complete audit reports and propose improvement recommendations;

4.Good communication skills and a strong team spirit, with the ability to communicate effectively with clients, suppliers, and internal teams;

5.Good English reading and writing skills to support work on international projects;

6.High professional ethics and strong sense of responsibility, able to work under pressure and adapt to travel requirements.