微创神通医疗科技（上海）有限公司
医疗器械体系工程师 - 国际QMS
3 months ago
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Important information
Contract type:
Permanent
Location:
Shanghai, China
Work mode:
Onsite
Published on:
31 August 2026
What they need
该职位来源于猎聘 工作内容： 1. 组织开展国际质量体系认证、审核的前期准备、迎审安排及推进整改和外部沟通反馈。 2. 支持海外经营质量体系的建立、维护和优化。 3. 持续优化质量管理体系，识别转化满足目标国家市场的法规要求。 4. 组织开展内审员、质量活动、质量培训相关策划与实施、评价与改进。 5. 质量数据的收集分析，向外部监管机构提交年度自查和上报等事项。 岗位要求： 1. 专业能力：熟悉国内外医疗器械质量体系相关法规标准 2. 语言能力：良好的英文读写和口语沟通能力 3. 认证资质：具有ISO13485体系内审员资质
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