医疗器械&IVD审核员 Medical device & IVD device auditor

Jobbeschreibung

医疗器械 modify and improve audit materials according to the comments of the reviewers 充分准备并按期完成公司安排的审核任务，督促客户整改不符合项，根据评审员意见修改完善审核资料 Complete the technical file assessment task arranged by the company on schedule 按期完成公司安排的技术文档评审任务 Timely feedback to relevant personnel on various problems in the work and actively cooperate in solving problems; Understand customer needs and provide feedback to relevant departments during the assigned task handling 及时向相关人员反馈工作中存在的各种问题，并积极配合解决问题；在分配任务处理过程中，了解客户需求，并向相关部门进行反馈 Adhere to the audit principle in the audit work, abide by the auditor’s code of conduct and the company’s regulations, pay attention to your words and deeds, and safeguard the company’s interests and image 在审核工作中坚持审核原则，遵守审核员的行为规范和公司的各项规定，注意自己的言行，维护公司利益和形象 Timely apply, maintain, and extend own auditor/expert qualification through audit practice, experience exchange, self-study and training regarding regulations, standards and product knowledge. 通过审核项目实践、经验交流、自学以及有关法规、标准和产品知识的培训，及时申请、维护并扩充自身的审核员/专家资格 Actively participate in the relevant training work arranged by the company 积极参加公司安排的有关培训工作 Provide advice on audit-related work and also other work of the company 提供与审核相关的工作及公司其他各项工作的建议。 Job Requirements: 4 years (or more) relevant practical experience in the field of healthcare products, such as medical device or pharmaceutical industry, science, laboratories, notified bodies, examination centers or facilities that test or manufacture (IVD) medical devices. Two out of these four years shall be demonstrated in the design, manufacture, testing or use of the device or technology. 在医疗产品领域，包括不限于（体外诊断）医疗器械或制药行业、科研机构、实验室、公告机构、检验中心或从事医疗器械检测或设计制造的机构等，拥有4年（或以上）相关工作经验。其中，至少2年有研发，生产或质检等有源医疗器械，无源医疗器械或IVD产品相关经验。 Minimum a Bachelor’s degree in science and engineering related discipline. 理工科相关专业，大学本科以上学历 Familiar with ISO 13485 and EU CE certification for medical devices. 熟悉ISO 13485 和 欧盟医疗器械CE认证专业知识 Familiar with the safety, performance, risk management, sterilization, and biologic evaluation requirements of MDD be able to withstand the corresponding work pressure and adapt to frequent business trips. 良好的语言表达能力，英语读写能力强；能承受相应的工作压力，适应频繁出差 Strong communication skills and team spirit. 较强的沟通能力和团队合作精神