该职位来源于猎聘 工作职责Responsibilities  负责医疗器械各个项目的流程确认和验证工作，协助全球项目转移并落地。

 Be responsible for the all processes verification and validation, to assist the global transfer projects launch.  主导处理客户抱怨，组织团队对投诉不良事件进行分析并制定纠正预防措施，完成跟踪验证；

 Lead in handling customer complaints, organize the team to analyze the complaints, formulate corrective and preventive measures, and complete the verification.  调查并分析生产中的异常问题，找到解决方案(涉及工艺，管控方法，工具设备，原材料等)；

 Investigate and analyze abnormal in production and find solutions (involving process, control methods, tools and equipment, raw materials, etc.);  负责识别内外部CAPA需求，并进行原因分析并制定纠正预防措施；以及CAPA的跟踪，报告及解决。  Be responsible for identifying internal and external CAPA requirements, conducting cause analysis and formulating corrective and preventive measures; And CAPA tracking, reporting and resolution.  负责质量管理体系文件的编制，评审及培训工作；  Be responsible for the preparation, review, and training of quality management system.  负责与质量相关SOP的编制、审核、维护；  Be responsible for the preparation, review, and maintenance of quality related SOPs.  年度质量管理体系内外审：组织公司内审，协调完成公司外审，并跟踪不符合项的整改措施。  Annual internal and external audit of quality management system: organize the internal audit, coordinate, and complete the external audit, and track the rectification measures of non-conformities.  负责对QC团队进行相应的质量工具、方法和能力培训，提升QC团队的工作一致性；  Be responsible for training QC team on corresponding quality tools, methods, and abilities to improve the inspection consistency.  协助进行供应商质量管理，负责制定不良来料的围堵措施和原因分析，督促供应商的持续改进；  Assist in supplier quality management, be responsible for formulating containment measures and cause analysis of defective materials and supervise supplier continuous improvement.  协助质量QC团队的日常管理，确保各工艺关键控制点按规定检验；  Assist in daily management of QC team to ensure all key process control points are inspected as required. 技能要求Required skills  熟悉医疗器械管理体系ISO13485及质量管理体系ISO9001；  Familiar with ISO13485 and ISO9001.  熟悉和掌握医疗类质量认证体系、认证流程及法规，如CE，EU MDR等；  Be familiar with and master the medical quality certification system and certification process, such as CE, EU, MDR, etc; 医疗器械法规  有一定的数据统计分析能力，熟悉SPC，MSA，GR&R等质量管理工具或方法；  Data statistics and analysis ability, and be familiar with SPC, MSA, GR & R and other quality management methods;  良好思维逻辑能力、人际交往和沟通能力；  Good thinking and logic skills, interpersonal and communication skills;  熟练使用office软件；  Familiar with office software;  熟悉测量工具：卡尺，角度尺，投影仪等；  Familiar with measuring tools: caliper, angle ruler, projector, etc;

 有一定管理及带队经验尤佳。  Have experience in team management if preferred. 认职资格Identify job qualification  本科及以上学历  University degree or above

 5-8年以上质量管理工作经验;  At least 5 to 8 years’ working experience in quality management;  具备一定的领导能力，具备分析判断和处理问题的能力；  Have leadership ability and the ability to analyze, judge and deal with problems;  有良好的沟通能力，处理跨部门之间的相关问题。  Good communication skills, dealing with cross departmental issues.