审核员 Auditor

4 days ago

Shanghai, Shanghai, China TÜV Rheinland Group Full time CN¥50,000 - CN¥150,000 per year

Job Responsibilities:

  • 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;
  • 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;
  • 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;
  • 及时完成公司安排的技术文件的评审工作;
  • 积极参加公司安排的有关培训工作;
  • 提供与审核相关的工作及公司其他各项工作的建议。
  • perform the audit tasks arranged by the company, provide timely feedback to the relevant personnel on various issues arising from the audit, and actively cooperate to solve the problem; understand customer needs in the audit and feedback to the relevant departments;
  • adhere to the audit principles in the audit work, comply with the auditor's code of conduct and the company's regulations, pay attention to their own words and deeds, and safeguard the interests and image of the company;
  • complete the preparation of audit information in a timely manner, communicate with the customer before the audit, urge the customer to rectify non-conformities, and modify and improve the audit information according to the opinions of the licensing staff;
  • complete the review of technical documents arranged by the company in a timely manner;
  • Actively participate in the training work arranged by the company;
  • Provide suggestions on audit-related work and other work of the company.

Job Requirements

  • 具备ISO 13485 和 欧盟医疗器械CE认证专业知识;
  • 熟悉MDD & MDR 或 IVDD & IVDR 等法规;
  • 熟悉有源医疗器械, 或无源医疗器械, 或体外诊断医疗器械的相关安全,性能,风险管理,灭菌,生物学评价和临床评价要求等知识;
  • 四年以上医疗器械领域的全职工作经验,如医疗器械或制药行业的实验室,公告机构,检验中心,医疗器械生产制造企业。 有研发经验优先考虑;
  • 本科及以上学历,学士学位优先考虑;专业范围:生物学,微生物学,医学, 药学,化学或生物化学,电子电气,机械,生物工程, 物理学或生物物理学,计算机和软件技术,人体生理学,材料科学。
  • 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,适应经常出差;
  • 具有良好的沟通能力和团队合作精神。
  • Specialized knowledge of ISO 13485 and CE marking of medical devices in the EU. 2;
  • Knowledge of MDD & MDR or IVDD & IVDR regulations. 3;
  • Knowledge of safety, performance, risk management, sterilization, biological evaluation and clinical evaluation requirements for active medical devices, passive medical devices, or in vitro diagnostic medical devices;
  • four (4) years of full-time experience in the medical device field, such as medical device or pharmaceutical industry laboratories, notified bodies, testing centers, medical device manufacturing companies. R&D experience is preferred;
  • Bachelor's degree or higher, preferably in biology, microbiology, medicine, pharmacy, chemistry or biochemistry, electrical and electronics, mechanical, bioengineering, physics or biophysics, computer and software technology, human physiology, materials science.
  • good language skills, good English reading and writing skills; able to work under pressure and adapt to frequent business trips;
  • good communication skills and teamwork spirit.

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