Quality Engineer Team Leader

Responsibilities

• 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。
• 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。
• Familiar with ISO 13485 quality management systems, holding an internal auditor certificate; familiar with relevant regulations such as FDA QSR
  820 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 QSR
  820、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。
• 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。
• 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。
• 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。
• 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。
• 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。
• 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。
• 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。

• 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。
• 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…