Working Location 工作地点
Suzhou 苏州市
Primary Purpose Summary 主要目标概述
The primary objective of the Qualification Engineer Management Trainee is to cultivate core talent in quality qualification, focusing on end-to-end management of new product, mold, and equipment qualification. Through structured training, the candidate will master quality standard development, change qualification, and continuous improvement, ultimately advancing to independently lead complex quality projects.
该职位旨在培养质量验证领域的核心人才，专注于新产品、新模具及设备验证的全流程管理。通过系统性培训，候选人将掌握质量标准的制定、项目变更验证及持续改进能力，最终成为能够独立主导复杂质量项目的工程师。
Key Responsibilities? 核心职责
- Lead full-cycle qualification activities? (IQ/OQ/PQ) for new products, molds, and production equipment, ensuring compliance with customer specifications and internal quality standards
主导新产品、新模具及生产设备的?全周期验证活动?（IQ/OQ/PQ），确保符合客户规格及内部质量控制要求
- Design and execute accelerated testing, analyze data, and generate validation reports
设计并执行加速测试方案，分析测试数据并生成验证报告
- Develop ?product specifications? based on customer requirements, including standardized definitions for reference samples, color limits, and defect criteria
根据客户需求制定?产品规格书?，包括标样管理、颜色限度版及缺陷限度版的标准化定义
- Optimize ?Quality Control Plans (QCP), integrating SPC tools to monitor Critical-to-Quality (CTQ) characteristics
优化质量控制计划（QCP），整合SPC（统计过程控制）工具监控关键质量特性（CTQ）
- Lead validation for product change projects, perform FMEA risk assessments, and track CAPA closure
主导产品变更项目的验证，完成风险评估（FMEA）及纠正措施（CAPA）的闭环追踪
- Identify quality improvement opportunities (e.g., measurement method optimization, localization validation), and promote automated inspection technologies (e.g., machine vision)
识别质量改进机会（如测量方法优化、本地化生产验证），推动自动化检测技术（如机器视觉）的应用
- Collaborate with R&D on ?technology transfers for new materials/processes, developing executable quality acceptance criteria
协同研发部门完成新材料/工艺的?技术转移，编制可执行的质量验收标准
Required Qualifications 任职要求
- Bachelor / Master degree in Materials Science, Chemical Engineering, Mechanical Engineering, or related fields
材料科学、化学工程、机械工程或相关专业应届本科或硕士学历
- Foundational knowledge in quality validation, including FMEA, SPC, and DOE methodologies
掌握质量验证基础知识，包括风险评估（FMEA）、统计过程控制（SPC）及实验设计（DOE）方法论
- Familiarity with basic laboratory instruments (e.g., HPLC modules, thermal analyzers) and data analysis tools (Excel advanced functions, Minitab basics)
具备基础实验室仪器操作技能（如HPLC基础模块、热分析仪）及数据分析软件（Excel高级函数、Minitab入门应用）
- Hands-on experience through academic research, campus innovation projects, or internships (e.g., summer internships in pharmaceutical/medical device companies)
具有实验室科研、校内创新项目或相关行业?实习经验?（如制药/医疗器械企业暑期实习）
- Proficient in English communications
熟练的英语沟通能力
- Teamwork and strong collaborative skills
优秀的团队协作能力