1.    Possess excellent independent judgment and decision-making abilities, and be capable of leading the team to analyze and resolve complex, non-routine quality issues in the production process using testing equipment and professional methods. 
具备卓越的独立判断与决策能力，能带领团队运用检测设备及专业方法分析并解决生产过程中的复杂、非常规质量问题。
2.    Strong data analysis capabilities, proficient in using quality tools such as the 7 QC Tools, SPC (Statistical Process Control), and FMEA (Failure Mode and Effects Analysis); those proficient in statistical analysis methods are preferred. 
具备熟练的数据分析能力，熟练运用 QC 七大工具、SPC（统计过程控制）、FMEA（失效模式与影响分析）等质量工具，精通统计分析方法者尤佳。
3.    Familiar with ISO 13485 quality management systems, holding an internal auditor certificate; familiar with relevant regulations such as FDA QSR820 and NMPA (National Medical Products Administration), and those with compliance management experience are preferred. 
熟悉 ISO 13485、ISO 9001 质量管理体系，持有内审员证书；熟悉 FDA QSR820、CFDA（国家药品监督管理局）等相关法规，具备合规管理经验者优先。
4.    Master comprehensive inspection technologies, familiar with the application and maintenance of optical inspection equipment and various testing tools in the production process, and able to guide team members in standardized operations. 
掌握全面的检验技术，熟悉光学检验设备及生产过程中各类检测工具的应用与维护，能指导团队成员规范操作。
5.    Have relevant knowledge and practical experience in lean production, and be able to promote the optimization of production quality processes in combination with lean concepts. 
具备精益生产相关知识与实践经验，能结合精益理念推动生产质量流程优化。
6.    Proficient in using office software, familiar with the operation and application of quality control systems such as SAP QM, and able to achieve efficient management of the team's quality work through the system. 
熟练使用办公软件，熟悉 SAP QM 等质量管控系统的操作与应用，能通过系统实现团队质量工作的高效管理。
7.    Possess good oral and written English skills, and be able to smoothly carry out cross-departmental and cross-level English communication and document processing. 
具备良好的口头与书面英语能力，能顺畅开展跨部门、跨层级的英文沟通及文档处理工作。
8.    Have a strong sense of responsibility and a proactive work attitude, able to withstand high-intensity work pressure and lead the team to respond to various quality challenges.
具备强烈的责任心、积极进取的工作态度，能承受高强度工作压力，带领团队应对各类质量挑战。
9.    Possess excellent team leadership, communication, coordination and motivation abilities, able to effectively unite team forces and improve the team's professional quality and work execution. 
具备出色的团队领导、沟通协调及激励能力，能有效凝聚团队力量，提升团队专业素养与工作执行力。
10.    Have excellent goal management and plan execution capabilities, able to reasonably assign work tasks and promote the team to efficiently achieve quality control objectives. 
具备优秀的目标管理与计划执行能力，能合理分配工作任务，推动团队高效完成质量管控目标。
 

1.    Team Management: Establish the organizational structure and working mechanism of the production quality team, clarify the job responsibilities and performance objectives of team members; be responsible for the recruitment, training, performance appraisal and career development planning of team members, so as to improve the overall professional competence and cohesion of the team. 
团队管理：搭建生产质量团队组织架构与工作机制，明确团队成员岗位职责与绩效目标；负责团队成员的招聘、培训、绩效考核与职业发展规划，提升团队整体专业能力与凝聚力。
2.    Quality Planning and Execution: Lead the quality planning of the production process, formulate production quality control plans, inspection standards and processes, ensure that quality control covers the entire production process (incoming materials, production process, finished products) and continuously meets design/customer requirements. /
质量策划与执行：主导生产过程质量策划，制定生产质量管控方案、检验标准与流程，确保质量管控覆盖生产全流程（来料、制程、成品），并持续符合设计 / 客户要求。
3.    Establishment and Maintenance of Inspection System: Organize the creation, revision and maintenance and review of inspection instructions for semi-finished products and finished products as well as relevant quality documents; be responsible for the quality training, skill certification and daily guidance of inspectors and operators to ensure standardized and accurate inspection work. 
检验体系搭建与维护：组织创建、修订并维护及审阅半成品、成品检验指导书及相关质量文件；负责检验员、操作员的质量培训、技能认证与日常指导，确保检验工作规范、准确。
4.    Quality Management in Product Transfer: Lead the quality planning and compliance management during the product transfer process, strictly follow the relevant requirements of NMPA (National Medical Products Administration), formulate product transfer quality control plans, conduct quality risk assessment, verification and validation during the transfer process, and ensure the quality compliance and controllability of the product transfer process. 
产品转移质量管控：主导产品转移过程中的质量策划与合规管理，严格遵循 NMPA（国家药品监督管理局）相关要求，制定产品转移质量管控方案，开展转移过程中的质量风险评估、验证与确认工作，确保产品转移过程质量合规、可控。
5.    Quality Inspection and Release: Supervise the team to complete the full-process product inspection in accordance with inspection instructions, review product inspection records and reports, be responsible for the quality release decision of finished product shipments, and ensure that non-conforming products do not flow into the market. 
质量检验与放行：监督团队按检验指导书完成产品全流程检验工作，审核产品检验记录和报告，负责成品出货质量放行决策，确保不合格产品不流入市场。
6.    Complaint Handling and Corrective and Preventive Actions: Coordinate the handling of internal and external customer quality complaints, organize the team to conduct root cause analysis, formulate and track the implementation effect of necessary corrective and preventive actions; quickly formulate and implement containment plans for end customer complaints to reduce quality risks. 
投诉与纠正预防：统筹处理内外部客户质量投诉，组织团队开展原因分析，制定并跟踪必要的纠正和预防措施的执行效果；针对外部客户投诉，快速制定并实施围堵方案，降低质量风险。
7.    Technical Support and Cross-departmental Collaboration: Provide professional production quality technical support in response to the needs of production, R&D, procurement and other relevant departments; establish a good cross-departmental communication and collaboration mechanism to promote the resolution of cross-departmental quality-related issues. 
技术支持与跨部门协作：应生产、研发、采购等相关部门需求，提供专业的生产质量技术支持；建立良好的跨部门沟通协作机制，推动解决跨部门质量相关问题。
8.    System and Continuous Improvement: Lead the effective operation of the integrated quality and environmental management system in the production link, organize internal quality audits and system maintenance; lead the team to identify production quality improvement opportunities, promote the implementation of quality improvement projects, and continuously improve the production process quality and team work efficiency. 
体系与持续改进：主导质量和环境整合体系在生产环节的有效运行，组织开展内部质量审核与体系维护；带领团队识别生产质量改进机会，推动质量改进项目落地，持续提升生产过程质量与团队工作效率。
9.    DHF Review: Organize the review of product verification documents and updated DHFs (Design History Files) for sustaining products to ensure the continuous compliance of product quality. 
设计文档评审：组织评审进入维持阶段的产品验证报告以及更新的 DHF（设计历史文件），确保产品质量持续合规。
10.    Complete other tasks related to production quality team management and quality control assigned by superiors. 
其他任务：完成上级领导分配的其他与生产质量团队管理及质量管控相关的工作
 

Your ZEISS Recruiting Team