Quality AM

• Analysis Corporation procedures change impact to China QMS and business, collect Medical Device related law, regulatory requirement, lead regulatory update requirements gap analysis. 收集医疗器械相关法律、法规要求，主导法规更新要求的差异分析。 • Implement Company business philosophy and operating principles. Understand QMS requirement from 1) corporation; 2) Applicable local regulatory/laws; 3) company operations. Be responsible to the QMS contact window with corporation and procedures change analysis from corporation to Greater China QMS and business impact. 贯彻公司经营理念和经营原则，充分理解来自1)公司总部；2) 当地适用的法律和法规；3)公司运营对QMS的要求。作为QMS对接总部的联系窗口，分析总部流程变更对大中华区质量管理体系和业务的影响。 • Work closely with each business unit and functional team, improve and maintain Greater China quality system structure, procedures, work instructions and quality records to meet corporation and relevant law and regulatory requirements. 与各业务部门和职能团队密切合作，完善和维护大中华区质量体系、程序、工作指导书和质量记录, 以符合总部和相关法律法规的要求。 • Be responsible for the implementation and execution of activities that are associated and relevant to company internal audit, improve the quality management system (QMS), implement per company quality management guidelines and goals, make the Quality system work efficiently. 负责实施和执行与公司内审相关的活动，改进质量管理体系(QMS)，按公司质量管理方针和目标实施，使质量体系有效工作。 • Lead the team to be responsible for leading the quality management of suppliers, distributors, quality management, post service management, and assist line manager for other external audits. 带领团队负责主导供应商质量管理、经销商质量管理、供应链质量管理、售后服务管理，协助部门经理进行其他外部审核。 • Monitor and follow up the CAPA/NC/SCAR status, identify opportunities and actively drive for continuous quality improvements within the organization. 监控和跟踪CAPA/NC/SCAR的状态，识别机会，并积极推动组织内部的持续质量改进。 • Assist line manager to identify the QMS training matrix per job title, lead regulatory and QMS training. Influence and drive BU/function team to enhance organization’s quality & compliance awareness by organizing /conducting new employee quality training, annual company quality training and other daily communication and propaganda activities of quality initiatives. 协助部门经理确定每个岗位的质量管理体系培训矩阵，主导相关员工的法规要求和质量管理培训。通过组织/开展新员工质量培训、年度公司质量培训和其他日常质量倡议的沟通和宣传活动，影响和推动部门/职能团队提高组织的质量和合规意识。 • Assist line manager to collect and perform quality performance measurements, data analysis and report monthly, assist to organize and conduct company Quality Management Review. 协助部门经理收集和执行质量绩效测量，数据分析和月度报告，协助组织和实施公司质量管理评审。 • Proactively participant medical device law and regulatory knowledge learning via various way - e-net, classroom training, self-learning. 通过各种途径积极学习有关法律和法规知识, 学习方式包括网上学习, 教室培训, 及自学等。 • Other related tasks assigned by line manager 部门经理分派的其它相关任务。