Intuitive
Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA
US · Peachtree Corners · Peachtree Corners, GA, United States · Remote · Full-time · Lead
要求时区 UTC+5.5（与北京时间可重叠约 6.5 小时，可协调）
Salary not stated
AI summary
About the company
Intuitive是全球领先的机器人辅助手术及微创护理企业，核心产品为da Vinci手术系统、Ion等，致力于通过技术革新优化手术效果，改善患者康复体验。
Role overview
该岗位为全职远程职位，隶属于Intuitive的全球供应链审核团队，向全球供应链审核总监汇报。负责全球第三方物流（3PL）等供应商的质量体系管控、风险导向审核、合规性推进及流程改进，需符合全球医疗设备监管标准，推动供应链质量成熟度提升。
Responsibilities
- 主导全球3PL质量管控与合规体系建设
- 执行风险导向的供应商主任审核
- 推动供应链质量流程改进与QMS优化
- 管理SCAR/CAPA全流程及供应商名录治理
- 作为SME支持FDA、公告机构等监管审核
Requirements
- 具备ISO 13485主任审核经验，主导全球多站点外部审核
- 精通21 CFR Part 820、ISO 13485等医疗设备监管标准
- 有全球3PL、冷链等供应商质量审核经验
- 熟练使用Trackwise、SAP、Agile等QMS平台
- 本科及以上学历，对应12/8/5年相关工作经验
Nice to have
- 有医疗设备行业3PL、冷链物流审核管理经验
- 熟悉医疗设备环境下服务供应商与分销商审核
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Excerpt
Company Description It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like…
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