高级供应商质量工程师（SQE） 岗位概述 本岗位面向具备医疗器械制造及供应商质量管理经验的专业人才，负责推动供应商质量体系建设与持续改进，确保产品质量及合规性，支持业务稳健发展。 岗位职责 1. 负责医疗注塑及成品供应商的质量管理与持续优化 2. 确保供应商符合ISO 13485及相关法规要求，并作为采购领域专家（SME）提供支持 3. 主导供应商审核，包括流程审核、体系审核及合规性审核 4. 推动模具供应商过程验证一致性（包括FAT等） 5. 负责供应商不合格管理、SCAR跟踪、供应商变更管理及风险控制 6. 负责来料检验整体管理工作 7. 支持客户审核及相关法规检查 任职要求 1. 本科及以上学历，工程类相关专业（机械、生物医学、高分子等） 2. 5年以上供应商质量或质量工程相关经验（必备），涵盖供应商导入、来料质量管理及供应商绩效管理 3. 必备经验：医疗器械制造行业经验 优先经验： 1. 注塑（塑料零部件）相关经验 2. 成品装配环境经验 3. 熟悉ISO 13485、FDA 21 CFR Part 820 QMSR及中国GMP相关要求（优先） 4. 熟练掌握质量工具，如RCA、SPC、QCP等 5. 具备良好的细节意识和较强的合规导向 6. 英语流利，能够胜任审核及报告工作

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