【苏州供应商质量工程师招聘】-猎头顾问苏州招聘信息-猎聘

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猎头顾问 · 上海今仕企业管理咨询有限公司苏州分公司

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职位介绍: 工作职责： Supplier Quality Management Responsibilities are as the following aspects供应商质量管理职责含以下方面： • Establishes and ensures the Approved Supplier List is up to date 建立并确保最新的《批准的供应商清单》 • Establishes timely planning and execution of supplier audits 及时规划和执行供应商审核 • Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements 根据良好生产规范、ISO 标准和适用的法规要求进行供应商审核 • Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects 确保建立全面的测量系统，以监控供应商的质量/可靠性，并识别、纠正和预防缺陷 • Ensure technical support to QC, purchasing and production etc. departments 确保对QC、采购和生产等部门的技术支持 • Provide Quality Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. China GMP, FDA CFR part 820 and ISO 13485 regulations/standards will be the focus. 为供应商提供质量支持，包括审核/评估、检验技术支持、验证/确认活动、CAPA 和变更管理。中国GMP、FDA CFR 第 820 部分和 ISO 13485 法规/标准将是重点。 • Addresses Supplier Change Requests in compliance with procedures and regulatory requirements. 根据程序和法规要求处理供应商变更请求。 • Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline. 确保外包过程/产品验证活动按照程序并在规定的时间内执行和记录。 • Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements. 确保根据计划并遵守程序和法规启动、处置、批准和调查供应商不合格项要求。 • Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions. 任职要求： A minimum of a Bachelors Degree is required, preferable in Engineering, a Life Science or a related technical discipline. 本科及以上学历，工科、生命科学或相关专业优先。 4-7 years working experiences in Medical Device manufacturing environment is preferred.  4-7年医疗器械制造工作经验优先。 Fluent in Chinese and English 中英文流利 Knowledge of Medical device standards and regulations, such as China GMP, ISO13485, 93/42 EEC, 21 CFR part 820 具备医疗器械标准和法规知识，如中国GMP, ISO13485, 93/42 EEC, 21 CFR part 820 Certified for ISO 13485 internal auditor. 持有ISO 13485内审员证书 Good communication, organizational, negotiation and interpersonal skills 良好的沟通、组织、谈判和人际交往能力 Good analytical problem-solving skills.  良好的分析和解决问题的能力 Use of Agile, Oracle, EtQ, Minitab 使用Agile, Oracle, EtQ, Minitab Use of Microsoft office tools 使用微软办公工具 Good knowledge of statistical techniques 良好的统计技术知识

其他信息: 语言要求：不限; 行业要求：其他制造业

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