Senior Quality Engineer 高级质量工程师

Responsibilities 职责：

Quality Issue Resolution & Improvement: (35%)
Coordinate the resolution of supplier-related incoming material quality issues, production defects, and associated customer complaints. Drive suppliers to implement corrective and preventive actions (CAPA) and verify the effectiveness of corrective actions. Analyze trends in defective material to identify risks in material quality and supply chain stability, and advance supplier quality improvement initiatives.

质量问题处理与改进：协调处理供应商的来料质量异常、生产缺陷和相关的客诉，推动供应商实施纠正（纠正预防措施）并验证整改有效性。分析在线缺陷物料投诉的趋势，识别在物料质量和供应方面的风险，推进供应商质量改进。 (35%)

Supplier Quality Management: (30%)
Manage supplier audits, supplier performance evaluation, supplier agreements, and supplier change control. Establish and maintain comprehensive supplier quality records and documentation.

供应商质量管理：包括供应商审核、供应商绩效管理、供应商协议以及供应商变更，建立并维护供应商质量档案。(30%)

Cross-Functional Collaboration & Communication: (25%)
Collaborate with Procurement, R&D/Engineering (ESS), Quality, and other relevant team to participate in new supplier evaluation, qualification, and New Product Introduction (NPI). Support supply quality risk management and drive suppliers to implement Advanced Product Quality Planning, Production Part Approval Process (PPAP), and process capability validation.

跨部门协作与沟通：与采购、研发技术（ESS）、质量等相关部门协同，参与新供应商评估、确认、新产品导入及供应质量风险管控。推动供应商实施先期产品质量策划、PPAP（生产件批准程序）及过程能力验证。(25%)

To participate in all activities in compliance with relevant GMP and Quality System standards. （5%）

参与所有GMP和质量体系标准相关的活动。

Other tasks are authorized by the leader. （5%）

领导安排的其它工作。

Qualifications 要求：

Bachelor degree or above.

本科或本科以上学历。

Excellent team work and communication skills, exert significant influence with suppliers良好的团队合作和沟通技能；对供应商具备较强的影响力。

Good skills on planning, action oriented, drive for results, and deep thinking.良好的工作计划能力，注重行动，结果导向，深入分析。

Competencies: Good written and speaking English良好的英文读写能力

Proficient in office software and quality statistical tool , 熟练使用办公软件和质量统计工具。

Experience with Power BI or other digital tools is a plus.能熟练使用Power BI或其他数字化工具更好。

Experience: A minimum of 8 year experience in a quality assurance and/or in manufacturing environment. Medical Device or pharmaceutical industry is preferred 8年或8年以上的质量和/或生产方面的工作经验。医疗器械或制药行业优先。