工作职责Responsibilities
86 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。
86 Be responsible for the all processes verification and validation, to assist the global transfer projects launch.
86 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；
86 Lead in handling customer complaints, organize the team to analyze the complaints, formulate corrective and preventive measures, and complete the verification.
86 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)；
86 Investigate and analyze abnormal in production and find solutions (involving process, control methods, tools and equipment, raw materials, etc.);
86 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。
86 Be responsible for identifying internal and external CAPA requirements, conducting cause analysis and formulating corrective and preventive measures; And CAPA tracking, reporting and resolution.
86 负责质量管理体系文件的编制，评审及培训工作；
86 Be responsible for the preparation, review, and training of quality management system.
86 负责与质量相关SOP的编制、审核、维护；
86 Be responsible for the preparation, review, and maintenance of quality related SOPs.
86 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。
86 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.
86 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；
86 Be responsible for training QC team on corresponding quality tools, methods, and abilities to improve the inspection consistency.
86 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；
86 Assist in supplier quality management, be responsible for formulating containment measures and cause analysis of defective materials and supervise supplier continuous improvement.
86 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；
86 Assist in daily management of QC team to ensure all key process control points are inspected as required.

技能要求Required skills
86 熟悉医疗器械管理体系ISO13485及质量管理体系ISO9001；
86 Familiar with ISO13485 and ISO9001.
86 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；
86 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
86 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；
86 Data statistics and analysis ability, and be familiar with SPC, MSA, GR & R and other quality management methods;
86 良好思维逻辑能力、人际交往和沟通能力；
86 Good thinking and logic skills, interpersonal and communication skills;
86 熟练使用office软件；
86 Familiar with office software;
86 熟悉测量工具：卡尺，角度尺，投影仪等；
86 Familiar with measuring tools: caliper, angle ruler, projector, etc;
86 有一定管理及带队经验尤佳。
86 Have experience in team management if preferred.

认职资格Identify job qualification
86 本科及以上学历
86 University degree or above
86 5-8年以上质量管理工作经验;
86 At least 5 to 8 years’ working experience in quality management;
86 具备一定的领导能力，具备分析判断和处理问题的能力；
86 Have leadership ability and the ability to analyze, judge and deal with problems;
86 有良好的沟通能力，处理跨部门之间的相关问题。
86 Good communication skills, dealing with cross departmental issues.