QMS区域经理

该职位来源于猎聘 Accountable for the overall maintenance and continuous improvement of the plant Quality Management System (QMS), and for leading internal and external audits conducted by regulatory authorities (e.g., NMPA, FDA) and corporate. 全面负责工厂质量管理体系的维护与持续改进，负责监管机构（NMPA，FDA等）、公司总部等内外部审核。Responsible for the maintenance and continuous improvement of the plant’s Quality Management System (QMS), ensuring effective operation and full compliance with GMP, ISO 13485, 21 CFR Part 820, MHLW MO169, EU MDR, and BD corporate requirements, drive the effective execution of plant audits, management reviews, and CAPA processes. 负责工厂质量管理体系（QMS）的维护与持续改进，确保符合GMP、ISO 13485、21 CFR Part 820、MHLW MO169、EU MDR等法规和BD总部的要求并高效运行，推动工厂审核、管理评审及CAPA流程的有效执行；Responsible for internal quality system audits at the plant, including planning, execution, follow-up, and closure of internal audits. 负责工厂内部质量体系审核工作，包括内审的计划、实施、跟踪及关闭；Responsible for the preparation and coordination of official and third-party audits, including completion of corrective action reports and follow-up activities; this includes but is not limited to audits for new product registrations, change registration reviews, and unannounced inspections. 负责官方和第三方审核的准备、协调，完成整改报告及后续跟踪工作；包括但不限于新产品的注册审核，变更注册审核，飞检等；Responsible for the emergency response process for unannounced inspections, ensuring that the QMS of Suzhou1 consistently meets inspection readiness requirements. 负责飞检应急反馈流程，确保苏州一厂的体系能时刻满足飞检要求；Responsible for the preparation and coordination of corporate headquarters audits, including the completion of corrective action reports and follow-up activities. 负责公司总部审核的准备、协调，完成整改报告及后续跟踪工作；Responsible for driving the implementation and continuous improvement of global quality strategies, as defined by the corporate quality department, at manufacturing sites in China. 负责总部质量部门推动全球质量战略在中国工厂的实施并持续改进；Responsible for liaising with regulatory bodies and government authorities to ensure the company’s Quality Management System complies with all current applicable laws and regulations.负责与法规和政府主管部门对接，确保公司的质量体系符合当前适用的法律、法规；Responsible for managing the Document Control Center, including periodic document reviews, evaluation of external documents, and ensuring consistency of documentation across BD Corporate, MDS, and the Suzhou manufacturing site. 负责文控中心的管理工作，包括文件周期性审核，外来文件评估，保持BD总部、MDS和苏州工厂的文档一致性等；Responsible for controlling and tracking plant changes to ensure timely closure of all change activities.负责工厂变更的控制及跟踪，确保变更及时关闭；Responsible for collecting and analyzing post-market product complaint information, supporting the Shanghai team in post-market surveillance activities, and providing relevant documentation in accordance with PMQ requirements. 负责产品后市场投诉信息的收集及分析，支持上海团队的上市后监管，根据PMQ的要求提供相关文件；Responsible for promoting the company’s quality culture and enhancing employees’ awareness of quality and compliance. 负责公司质量文化的推广，提升公司员工的质量意识和合规文化；Other tasks assigned by manager. 其他QA经理指派的工作。