Quality Engineering Manager 质量工程经理

Responsibilities

1) Lead the team for quality incident and complaint investigations, corrective actions and preventative actions. Lead proactive problem identification and resolution efforts for quality related opportunities. Investigate issues, define and direct implementation of solutions. Perform regular statistical trend analysis and review to determine process quality capability, quality control acceptance, and initiate activities accordingly. （25%）
带领团队负责质量事件和投诉的调查，纠正及预防措施。针对质量的改进机会点可以前瞻性发现问题并努力寻找解决方案，调查问题，定义和执行措施。执行周期性的统计分析和回顾来确认过程质量能力，质量控制的接受能力，以及发起相对应的活动。

2) Supplier/Intercompany quality management to ensure raw materials/components quality performance. （25%）
供应商/兄弟工厂质量管理以确保原材料/部件质量绩效。

3) Involve in the generation/approval/review of validation studies, capability studies, FMEA, MSA, CSV and control plan as required. Lead or involve in risk analysis based on manufacturing experience where necessary. （15%）
根据需要参与验证研究，能力研究，失效模式分析, 测量系统分析，计算机化系统验证和控制计划的生成/批准/审核。带领或参与基于生产经验相关的风险分析。

4) Develop quality metrics/indicators to track performance and analysis data to develop and implement improvements. Lead implementing action to improve product quality and identifying areas for improvement. To proactively manage and develop the performance of team members through performance management, training, and development to meet the business needs and objectives. （15%）
设定质量指标来追踪绩效并根据数据分析来展开改善。领导产品的质量改善及识别改善区域。能自主的通过绩效管理，培训和发展来提升团队成员的绩效使其达到业务的需求及目标。

5) Ensure that compliance to regulatory (e.g. ISO 13485/MDR/QMSR/NMPA) requirements are maintained, revise procedures as required to meet compliance objectives. （10%）
确保符合法规（如ISO13485/MDR/QMSR/NMPA）的要求，更新程序来满足合规的目标。

6) To observe high standard of Occupational Health and safety in the workplace and to ensure that procedures are understood and applied in accordance with the Wound Management Policy. （5%）
遵守工作场所的职业健康和安全标准，按照伤口护理部门的方针确保规程得到理解并运用。

7) Other tasks are authorized by the leader. （5%）
领导安排的其它工作。

Qualifications :

☒ A minimum of 8 years’ experience in Quality & Engineering related work, with 3 or more years in a management role, knowledge of ISO13485, quality tools, statistics, process control, etc. Knowledge in six sigma is a strong plus.

至少8年质量和工程的相关工作经验，3年或更多管理经验，具备并掌握ISO13485，质量工具，统计，过程控制等，具备 6 sigma能力佳。

☒ Strong technical background and problem solving skills.

较强的技术背景和问题解决技巧。

☒ Bachelor degree or above, at least 3 years’ experience working within Medical Device / Pharmaceutical Industry.

本科学历或以上，至少3年在医疗器械/制药行业工作经验。

☒ Good awareness / understanding of company products, processes and procedures.

对公司产品，工艺和程序有良好的意识 / 理解。

☒ Strong analytical and communication skills are essential together with the ability on people management.

兼备较强的分析，沟通技巧和 人员的管理能力。

☒ Good written and oral English.

良好的英文读写能力