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JOB DETAILS

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研发质量经理

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Salary Negotiable

Location Shanghai

FULL_TIME

Consultant Grace Shi

JobRef 1211200/001

Date posted 16 January 2023

shanghai Healthcare/qa-ra 2023-01-16 2023-03-17 hospitality-and-catering 上海 CN Robert Walters https://www.robertwalters.cn https://www.robertwalters.cn/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true

建立、实施、监管和持续改进基于ISO13485和医疗器械生产和经营质量管理规范的质量管理体系; 组织和推动产品整个生命周期的风险管理活动

工作职责:

  • 建立、实施、监管和持续改进基于ISO13485和医疗器械生产和经营质量管理规范的质量管理体系
  • 组织和推动产品整个生命周期的风险管理活动,负责输出风险管理质量管理计划、定期风险管理报告等产品风险相关文档
  • 组织和推动产品全生命周期的质量问题,推进质量问题改进直至关闭,组织相关职能开展质量改进活动,确保产品质量改进和质量水平提升
  • 流程管理:确保产品的开发活动符合法规/质量管理体系的要求;确保设计转移前各个流程和活动符合公司体系的要求
  • 建立产品设计验证主计划,编制产品设计验证和相关设计变更验证方案和报告
  • 外部审核的接待与应对(CFDA,CE,FDA,PMDA,KFDA等),及外审结果整改跟踪,领导内审工作的安排与实施,包括内审计划的制定,内审实施及整改跟踪

任职资格:

  • 全日制本科及以上学历, 3年以上自研整机产品研发DQE 管理经验
  • 熟悉项目管理流程,精通FMEA、APQP、MSA、熟悉 6西格玛、DOE等质量工具
  • 熟悉ISO9001、QC080001、ISO13485体系,擅长质量控制,对供应商质量管理、客户投诉处理等有丰富经验
  • 具有对流程管理有一定程度的理解和见解,熟练运用质量管理的分析、工具和方法
  • 具有YY/T 0287(ISO 13485)或 GB/T19001 (ISO9001)内审员证书,或接受过同等水平的系统化的质量管理体系知识培训,需具备CE及FDA注册质量核查经验

Get in touch

contactConsultantImage

Grace Shi

+8621 5153 5862

grace.shi@robertwalters.com.cn

1607404 1607404 1607404
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