主要职责:
1. 负责公司ISO13485/QSR820质量体系的维护。
Maintain the ISO13485/QSR820 system;
2. 负责公司文件管理Fun88体育官网, 在MC 系统中进行文件的管理及维护。
Be responsible for document control in the MC.
3. 负责所有的审核, 包含内审及外部审核,客户审核。
Be responsible for all audits activities , including the internal audit, third party audit and customer audit.
4. CAPA 的协调管理, 协调各部门完成CAPA 。
Work as CAPA coordinator and complete CAPA in MC.
5. 负责变更管理的会议主导,并主导变更管理会议。。
Be responsible for change management, lead the meeting for changes.
6. 负责灭菌产品的放行。
Sterilized products release activities.
任职资格:
1. 有1到2年医疗器械行业的质量Fun88体育官网经验尤佳。
Have one to two years working experience in medical device field is prefer。
2.至少有1到2年质量体系维护Fun88体育官网经验。
Have one to two years working experience in QMS maintenance..
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