Describe major duties and responsibilities of the position.
描述该职位的主要职责和责任。
61 Stay updated with job procedures and manage work instructions.
保持与工作程序的最新状态并管理工作指导书。
61 Maintain current production documents.
维护生产现场设备主记录文档的当前版本。
61 Manage quality records and ensure their safety, effectiveness, and accessibility.
管理所有质量记录，确保其安全，有效，和易于获取。
61 Coordinate training and ensure its effectiveness.
负责培训任务的分配和协调，并确保培训的有效性。
61 Handle non-conforming product reports and control their movement.
管理不合格产品报告。控制不合格产品的流动，并确保根据不合格产品程序进行充分的调查和报告记录。
61 Oversee corrective and preventive actions. Monitoring CAPA trend, make sure effective quality improvement by CAPA.
管理纠正和预防措施。监控CAPA的趋势，确保CAPA可以有效地改善质量。
61 Ensure conformity with the quality management system and regulatory requirements.
对过程的执行进行检查，以确保符合质量管理系统和适用的法规要求。
61 Conduct Quality Management Review to ensure compliance with regulations and internal requirements.
执行质量管理评审，以确保质量系统符合法规和内部要求。
61 Maintain the quality management system effectively and sufficiently.
有效和充分地维护质量管理系统。
61 Assist in transferring designs to manufacturing, including quality control activities from production processes to shipment of the final product.
协助设计转移到制造，包括从生产过程到最终产品发货的质量控制活动。
61 Responsible for internal audits and support audit programs.
负责内部质量审计并支持审计计划。
61 Participate in third-party audits and inspections (ISO, Notified Body, China NMPA, etc.).
参与并支持第三方审计和检查（ISO，认证机构，中国NMPA等）。
61 Provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
为质量程序、系统、流程和程序的开发和维护提供监督，以确保符合政策，并确保服务的性能和质量符合已建立的内部和外部标准和指南。
61 Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
提供专业知识和指导，解释政策、法规和/或政府法规，以及内部法规，以确保合规。
61 Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
直接与运营部门合作，提供持续的流程分析监督，以执行要求并满足法规。
61 Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
领导审计和检查的准备，解决审计和检查的发现，并在所有阶段与审计组和检查员联络。
61 Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
准备报告和/或必要的文档（例如纠正和预防措施）并提供给内部和外部的相关利益方。
61 Coordinate legal requests in support of government investigations or litigations.
协调法律请求，以支持政府调查或诉讼。
61 Ensure the quality assurance programs and policies are maintained and modified regularly.
确保质量保证计划和政策得到维护和定期修改。
61 Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company’s mission globally.
促进全球统一标准，并使***实践共享，从而促进公司的全球使命的实现。
61 Perform other assigned duties.
执行其他分配的职责。