Talent Recruitment

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

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IVD试剂工艺工程师

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Minimum Education:

本科

Number of Recruits:

1

Experience requirements:

5-10年

Work area:

江苏省南京市浦口区

岗位职责：

1. 负责体外诊断试剂新产品的设计转换及生产导入相关工作;

2. 负责制造条件在研发过程中的落实和管理;具体是SOP，MBOM，DHR的撰写和维护;

3. 负责产品工艺的确认，保证产品工艺质量，负责在线产品工艺质量持续改进;

4. 负责产品生产关键工序和特殊过程的确认和验证工作;

5. 提高生产效率及降低生产成本，对产品工艺问题提出纠正和预防措施;

6. 跟进、解决体外诊断试剂生产异常问题;

7. 负责试产及量产过程BOM的更改及维护，保证BOM的准确性;

8. 负责试产及量产过程ECN的编制以及过程的统筹、跟踪;

9. 完成上级主管交待的其他工作事项。

 

任职条件：

1.本科及以上学历，生物技术、免疫学、医学检验等专业， 2.5年以上新产品导入、工艺验证及优化或者生产及工程化方面相关工作经验;

2.熟悉体外诊断技术，有体外诊断试剂产品开发和生产调配经验者优先;

3.熟悉产品质量控制方法，具备一定的故障分析能力;

4.良好的沟通能力和团队精神，责任心强，能承受一定的工作压力。

Jiangsu Medomics Medical Technology Co., Ltd.

Contact us

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Tel: 86 025-58601060

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E-mail: overseas@medomics-dx.com

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

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