engineering
Posted 2 weeks agoQuality Engineering Manager 质量工程经理
On-site
Responsibilities
- 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.
- Lead or involve in risk analysis based on manufacturing
- Lead implementing action to improve product quality and identifying areas for improvement.
Requirements
- 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。
- 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 Stay connected by joining our Talent Community .
Additional details
- Responsibilities 1) Lead the team for quality incident and complaint investigations, corrective actions and preventative actions.
- （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.
- 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.
- 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.
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