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If you are interested in joining us, please fill in the form below or send your resume to E-mail.zhouxc@aimsrobots.com
2025-03-31
Quality System Manager
Nanjing
|
5-10 years
|
Undergraduate
Job Responsibilities:
1. Familiar with the application process and specific requirements of ISO13485 quality system registration, familiar with the writing, organization and review of registration application materials;
2. Familiar with relevant laws and regulations of medical device ISO13485 quality system, with rich practical and management experience;
3. Have experience in quality management of medical devices and related products, responsible for the declaration, implementation and maintenance of the normal operation of the medical device quality system, annual review and communication with foreign counterparts;
4. Able to promptly coordinate and handle relevant issues that affect the normal operation of the quality system;
5. Have an internal auditor certificate and good communication and cooperation ability with all levels of regulatory agencies.
Job Requirements:
1. Full-time undergraduate degree or above, more than 5 years of practical experience in quality management of Class II or above medical devices;
2. Familiar with the relevant system requirements of Class II registration ISO13485, FDA or NMPA;
3. Those with regulatory experience are preferred.