工作内容 ：
1.按照客户的审核标准到现场进行质量控制和审核，撰写相关的审核报告并上传至公司。
2.组织或参与审核，实施审核工作。
3.评估客户的符合性，以便发放或维持认证
4.在审核结束后，或在指定的时间范围内，确保及时完成好的质量报告（包括费用申报）。
5.确保认证的后续工作。
6.促进知识共享。
1. Conduct quality control and audit to production site according to customer's audit criteria, write related audit reports and upload them to the company.
2. Organize or participate in the organization of the audit; Carry out the audit.
3. Assess client compliance in order to issue or maintain certification
4. Ensure timely production of good quality reports (including expenses claims) directly after the audit close-out, or within the designated time-frame (for referential demanding)
5. Ensure the follow-up of the certification
6. Contribute to the sharing of knowledge
工作要求 ：
1. 本科及以上学历，医疗器械(MD)设计、制造所涉及的相关专业。
2. 4年以上医疗器械或体外诊断器械研发、生产、质量管理或法规注册相关工作经验，熟悉行业运作，医疗器械或体外诊断器械法规和ISO13485标准，有CE产品认证经验者优先考虑；
3. 持有CCAA或IRCA的注册审核员资格者优先；
4. 良好的英语交流及报告撰写能力，能够接受英文课程培训；
5. 积极的工作态度，具有独立工作和抗压力，能适应出差；
6. 具备良好的沟通能力和团队精神
1. Bachelor degree or above, major in medical device (MD) design and manufacturing related.
2. At least 4 years of relevant working experience in the field of medical devices or in vitro diagnostic devices, involves in R&D, production, quality management or registration, familiar with industry operation, medical devices or in vitro diagnostic devices regulations and ISO13485 standards, experience in CE product certification is preferred;
3. CCAA and IRCA registered auditor qualification are preferred;
4. Good English communication and reporting skills, able to accept English course training;
5. Positive working attitude, independent and stress resistant, able to travel;
6. Good communication skills and team spirit

其他信息


所属部门：CER-体系认证事业群