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Open nowPosted 88 days ago

医疗质量体系实习生

anker-in/campushirecn495 open roles

Where
Shenzhen, Guangdong, Chinese Mainland
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Your applicationOpen now医疗质量体系实习生anker-in/campushirecn · Shenzhen, Guangdong, Chinese Mainland

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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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 88 days ago

anker-in/campushirecn median: 1 days open

The posting

安克实习生项目是面向正式校招岗位的人才培养与选拔通道。实习期间将按照校招标准进行系统的培养与综合评估，表现优秀者可直接获得校招转正机会，提前锁定正式校招席位。我们以严肃、长期的视角对待每一位实习生，也期待与你共同成长。 【你将参与】 1.体系策略 - 根据公司产品策略，协助完成产品全球市场准入工作（中国NMPA﹑美国FDA、欧盟CE-MDR等）的体系策划、组织和实施，制定产品体系审核策略； 2.体系认证 - 依据ISO13485，QS820和GMP的要求，结合IPD和PLM流程，协同研发编制DHF，DMR等体系文件，对产品相关的体系文件交付质量负责； 参与委托生产的设计转换工作，协助优化代工厂医疗器械生产质量体系，保证DHR文档真实，可追溯； 3.合规监管 - 协助与监管部门对接，处理各类事宜，积极完成相关监管任务； 4.合规维护 - 协助产品认证有效性维护和全生命周期的合规控制，参与设计变更对认证合规影响的评审并制定应对方案。负责法规的收集、解读及研究跟踪法规和标准变化趋势，及时组织内部切换，督促研发更改完善已上市产品的法规符合性； 5.合规意识 - 协助公司内部法规意识的建立，并根据需要举行法规知识培训； 6.协助编制修订体系文件和相关审核认证工作。

1.硕士及以上学历，通信类、电子类、化学类、生物医药、临床医学/技术英语等理工科专业，具备基础英语沟通能力； 2.了解有源器械中国NMPA，欧盟CE MDR或美国FDA等主流国家注册流程； 3.了解《医疗器械生产质量管理规范》、ISO13485、MDSAP、FDA QSR820等质量体系要求； 4.条理清晰、逻辑思维缜密、性格开朗活泼，具有良好的沟通协调能力，团队协作能力。

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