无源医疗器械审核员/Non-active Medical Device Auditor
Job Descriptions
1. Carry out the review tasks assigned by the company, promptly feedback various issues identified during the review to relevant personnel, and actively cooperate in resolving them; understand customer needs in the course of review and communicate such needs to the relevant departments
执行公司安排的审核任务，及时向相关人员反馈审核工作中出现的各种问题，并积极配合解决问题；在审核中了解客户需求并向相关部门反馈
2. Adhere to audit principles in the audit process, comply with the auditor's code of conduct and all company regulations, mind your words and deeds, and safeguard the company's interests and reputation
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
3. Prepare audit documentation in a timely manner, communicate with customers prior to audits, urge customers to rectify non-conformities, and revise and improve audit materials in accordance with the comments from certifier
及时完成审核资料的准备，与客户在审核前沟通，督促客户整改不符合项，根据发证人员的意见修改和完善审核资料
4. Timely complete technical document review tasks assigned by the company
及时完成公司安排的技术文件的评审工作
5. Actively participate in training sessions arranged by the company
积极参加公司安排的有关培训工作
6. Provide suggestions related to audit work and other tasks 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
1. Possess the qualification of a CCAA trainee auditor or certified auditor
具有CCAA实习或注册审核员资质
2. Good English listening, speaking, reading and writing skills, at least reaching CET-4 level
良好的英语听、说、读、写能力, 至少达到CET 4级水平
3. Bachelor’s degree or above, majoring in chemistry, biology, biomedical science, pharmacy or related fields
本科以上学历，化学、生物学、生物医学，药学等相关专业
4. Four years or more of work experience, including at least two years of experience in a non-active medical device manufacturing enterprise
四年及以上工作经验，其中至少两年无源医疗器械生产企业经验
5. Primarily engaged in product design and development, production, quality inspection, quality management, or regulatory affairs
主要从事于产品设计开发、生产，质量检验，质量管理或法规事务等方面工作
6. Good team spirit and customer service mindset
良好的团队合作及客户服务精神
7. Proactive attitude and ability to work under pressure; willing to travel frequently
具有主动精神并能够承受工作压力, 可经常出差