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Open nowPosted 7 days ago

医疗器械体系工程师-深圳

anker-in/campushirecn495 open roles

Where
Shenzhen, Guangdong, Chinese Mainland
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Your applicationOpen now医疗器械体系工程师-深圳anker-in/campushirecn · Shenzhen, Guangdong, Chinese Mainland

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The clock on this job

Early applications get read.

12.3% of postings close within 7 days. Measured by our own scanner across the market. anker-in/campushirecn postings stay open a median of 1 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.5%3 days
  3. 12.3%7 days
  4. 19.3%14 days
  5. 35.6%30 days
  6. 57.8%60 days
This job: posted 7 days ago

anker-in/campushirecn median: 1 days open

The posting

你将参与： 1.体系维护：在导师/团队指导下，参与医疗器械质量管理体系（ISO 13485、GMP）的运行、维护与持续改进。 2.文件与记录管理：负责质量手册、程序文件、作业指导书、记录表单的编制、修订、受控、发放与归档，保障可追溯。 3.审核支持：协助准备内审、管理评审及外部审核（NMPA 体系核查、CE、FDA 等）的相关资料，跟进不符合项整改。 4.软件质量支持：协助将 IEC 62304 软件生命周期、设计变更、配置管理纳入体系受控，支撑软硬件产品合规交付。 5.质量活动配合：参与 CAPA、不良事件、风险管理（ISO 14971）等质量活动的执行与记录。 6.成长培养：接受系统化带教与轮岗，逐步成长为可独立支撑质量体系运行的工程师。

1. 2027届毕业生，本科及以上学历，生物医学工程、医疗器械、质量管理、电子、软件等相关专业。 2.有医疗器械质量体系、质量管理或相关实习/项目/课程/竞赛经历者优先。 3.了解或学习过 ISO 13485、GMP、ISO 14971，接触 IEC 62304 者优先。 4.具备较强的文档编写与整理能力，注重细节、原则性、条理性好。 5.英语读写能力良好，能阅读英文标准（CET-6 或同等水平者优先）。 6.责任心强、学习能力强、沟通协作良好，愿意在质量体系领域成长发展。 加分项 在校期间获得奖学金（国家奖学金、校级及以上奖学金者优先）。 参加过 ISO 13485 内审员培训或体系相关培训/认证。 有有源器械、医疗软件或质量体系相关实习/项目经历。

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