Talent Recruitment

Focus on the diagnosis of pathogenic microorganisms in the reproductive tract and respiratory tract

IVD 质量体系工程师

面议

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Minimum Education:

本科

Number of Recruits:

Experience requirements:

5-10年

Work area:

江苏省南京市浦口区

职位描述： 1、熟悉国内外质量管理法规要求，协助上级建持续优化、完善公司质量管理体系;

2、制定和优化质量管理体系文件，协助规范各项质量控制流程和质量管理制度的实施;

3、组织协调公司外部审核工作，确保部门及公司顺利通过相关外部审核或认证;

4、负责制定部门内部审核计划及实施审核工作，输出整改报告，持续改进;

5、负责生产质量管控、质量管理过程监督及风险管理，对于异常情况及风险点及时汇报并提供相应的解决方案;

6、负责质量文件的建立、修订与审核管理工作，包括文件和记录的组织修订、收发、记录的编号下发、整理归档等，确保文件的适宜性和有效性，记录的合规性和可追溯性;

7、完成领导交代的其他工作。

任职要求：

1、本科及以上学历，生物工程相关专业优先;

2、有5年以上的医疗器械质量体系管理经验，具备完整外部审核应审经验;

3、精通中国GMP管理规范、ISO13485等法规要求，熟悉海外MDR/IVDR/FDA质量管理体系要求优先;

4、以结果为导向，具有良好沟通、协调、统筹、执行管理能力，较强抗压能力，有一定的文件编写能力;

5、具备内审员资格证者优先。

Jiangsu Medomics Medical Technology Co., Ltd.

Tel: 86 025-58601060

E-mail: overseas@medomics-dx.com

Address: Building 01, Phase 6, No.71, Xinghui Road, Jiangbei New Area, Nanjing, China

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