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有源医疗产品审核员 Active product auditor

Job ID: c1753

TÜV Rheinland

Permanent, Full Time

Nanshan

Immediately

Job Responsibilities:

  • Independently write relevant documents, such as audit plans, audit reports, etc.
    独立编写相关文件，如审核计划，审核报告等。
  • Complete on-site audit tasks independently or in collaboration with colleagues.
    独立或配合同事完成现场审核任务。
  • Review the customer's technical documents and complete the technical document review report.
    审核客户技术文档，完成技术文档审核报告。
  • As the lead auditor, collect, check and review the audit documents, submit them to the certification department, and reply to the questions raised by the certification department, and finally complete the case.
    作为主任审核员，收集，检查审核文件，提交发证部，并回复发证部提出的问题，最终完成结案。
  • Keep learning, maintain various qualifications, and expand them as much as possible.
    不断学习，保持各种资格，并尽可能的扩展资格。
  • Complete other tasks assigned by the active Medical team leader.
    完成有源医疗组长指派的其他工作。

    • Job Requirements:

  • Familiar with ISO 13485 and EU CE certification for medical devices，Familiar with the safety, performance, risk management requirements of MDD & MDR for active medical devices.
    熟悉ISO 13485 和 欧盟医疗器械CE认证专业知识，熟悉 MDD & MDR，熟悉有源医疗器械的安全、性能、风险管理等要求
  • More than 4 years of industrial background, with rich experience in product research and development, quality management or production management. Preferred in fields such as imaging, ultrasound, monitoring, diagnosis, treatment equipment, otolaryngology, medical software &AI products, etc.

    • 4年以上工业背景，产品研发， 质量管理或生产管理经验丰富。影像、超声、监护、诊断、治疗设备、耳鼻喉、医疗软件&AI产品等领域优先。

  • Minimum education is university degree in Bachelor.
    大学本科以上学历
  • Good language expression skills, strong English reading and writing skills; 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

    • We only accept applications submitted online through our application system. We cannot accept applications sent by email.

    What else you should know

    Job IDc1753
    Type of contractPermanent
    Type of employmentFull Time
    CompanyTÜV Rheinland

    Application deadline: as long as the job is listed on our career page, we are looking for suitable candidates (all genders welcome). We are looking forward to receiving your application.

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