【职位概述】
作为制造质量团队的核心成员，此岗位将主导产品全生命周期质量管控，通过数据驱动的方法减少过程缺陷，确保符合GEHC等国际质量体系标准。该职位需协同全球供应链团队，具备跨文化沟通能力和技术决策能力。
【核心职责】
1. 质量分析与改进
运用Minitab等工具进行缺陷数据统计分析，主导8D报告及CAPA制定
管理NCR/MRB流程，推动非符合物料库存降低（目标年降15%）
执行SPC监控，识别过程变异趋势并联动工艺工程师优化
2. 跨职能协作
作为SQE与制造工程接口，主导供应商质量缺陷的根因分析
对接美国/印度工厂客户，处理CT车间及医院现场客诉（响应时效≤24h）
维护DHR电子记录系统，确保符合21 CFR Part 11合规要求
3. 体系运营
主导年度质量内审，推动ISO 13485体系落地
开发标准化作业程序（SOP）并培训产线人员
【任职要求】
硬性条件
- 机械/机电工程专业，统招本科及以上学历，3年以上相关经验
- 英语CET-6以上（口语流利可以熟练沟通）
技术能力
- 熟悉 APQP, FMEA, MSA, SPC, PPAP, CP 等质量工具；
- 具备CPK/PPK分析经验
- 熟悉精益生产基础
软性素质
- 能领导5-8人跨文化团队
- 可同时管理3个以上质量改进项目
- 可同时管理3个以上质量改进项目
优先条件
六西格玛绿带认证
汽车/医疗设备行业经验
具备供应商审核经验（VDA6.3加分项）
专业路径：高级质量工程师→质量经理→质量总监
认证建议：优先考取ASQ CQE或IRCA内审员资格

Job Overview‌
As a core member of the manufacturing quality team, you will lead end-to-end product quality control, leveraging data-driven methodologies to reduce process defects and ensure compliance with GEHC and other international quality standards. This role requires collaboration with global supply chain teams, cross-cultural communication skills, and technical decision-making capabilities.
‌Key Responsibilities‌
‌1. Quality Analysis & Improvement‌
Utilize Minitab for defect data analysis and lead 8D reports/CAPA development
Manage NCR/MRB processes, drive non-conforming material inventory reduction (15% annual target)
Implement SPC monitoring, identify process variation trends, and collaborate with process engineers for optimization
‌2. Cross-functional Collaboration‌
Serve as the interface between SQE and manufacturing engineering, leading root cause analysis of supplier quality defects
Liaise with US/India factory clients, addressing CT workshop and hospital site complaints (24-hour response SLA)
Maintain DHR electronic records to ensure 21 CFR Part 11 compliance
‌3. System Operations‌
Lead annual quality audits and drive ISO 13485 implementation
Develop SOPs and conduct training for production line personnel
‌Qualifications‌
‌Category‌ ‌Requirements‌
‌Hard Requirements‌ - Bachelor's in Mechanical/Electrical Engineering (or 3+ years experience + HS diploma)
- CET-6 English proficiency (fluent speaking)
‌Technical Skills‌ - Proficient in GD&T/FMEA tools
- CPK/PPK analysis experience
- Lean manufacturing fundamentals
‌Soft Skills‌ - Ability to lead 5-8-member cross-cultural teams
- Manage 3+ quality improvement projects concurrently
‌Preferred Qualifications‌
Six Sigma Green Belt certification
Automotive/medical device industry experience
Supplier audit experience (VDA6.3 preferred)
‌Career Path‌
‌Technical Track‌: Senior Quality Engineer → Quality Manager → Quality Director
‌Certifications‌: ASQ CQE or IRCA Auditor certification recommen