QMS Staff Engineer

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: Customer/Commercial Quality Job Category: People Leader All Job Posting Locations: Beijing, China Job Description: 在管理者代表和质量管理负责人的领导下，负责建立、实施、维护和持续改进质量管理体系，确保符合医疗器械法规、ISO 13485及公司质量要求。负责质量体系符合性管理、文件与记录管理、培训管理及质量体系绩效监控，支持组织持续保持法规符合性和体系有效性。 Under the leadership of the Management Representative and Head of Quality Management, responsible for the establishment, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure compliance with applicable medical device regulations, ISO 13485, and company requirements. 1. 质量管理体系管理Quality Management System (QMS) 在管理者代表和质量管理负责人的领导下，建立、实施、维护并持续改进符合中国医疗器械GMP、ISO 13485及公司包括强生及强生科技、BU等内部要求以及其他适用法规要求的质量管理体系。 Under the leadership of the Management Representative and Head of Quality Management, Establish, implement, maintain, and continuously improve the Quality Management System in accordance with China Medical Device GMP, ISO 13485,Company the company's internal requirements including those of Johnson & Johnson, Johnson & Johnson Med Tech and the relevant business units, and other applicable regulatory requirements. 确保各项质量体系流程持续有效运行，并始终处于审核和检查就绪状态。 Ensure all quality processes remain effective, compliant, and audit-ready. 制定并维护相关程序文件（SMP）、操作程序(SOP)及质量记录。 Develop and maintain the SMPs 、SOPs, and quality records. 推动质量目标的制定与落实，跟进NC/CAPA/KPI/Metrics等关键绩效指标（KPI）,并通过关键绩效指标（KPI）监控质量体系运行情况。 Drive the establishment and implementation of quality objectives, follow up on NCs, CAPAs, KPIs and other metrics, and monitor the performance of the quality system through KPIs. 负责管理评审实施，确保改进措施得到有效落实。Responsilbe for Management Review implementationand and ensure follow-up actions are effectively completed. 支持受托方的质量体系改进和优化。Support external partners in improving and optimizing their Quality Management Systems to ensure ongoing compliance and operational effectiveness. 2. 符合性管理Compliance management 负责质量体系符合性监测与评估；跟踪法规、标准及公司要求的变化并推动落实；开展符合性差距分析并推动整改措施实施；确保公司持续符合相关法律法规及相关检查指导原则要求。 Monitor and assess QMS compliance;Track regulatory, standard, and corporate requirement changes and ensure implementation; Conduct compliance gap assessments and support remediation activities; Ensure ongoing compliance with applicable regulatory requirements. 配合内部审核、监管检查及第三方审核准备工作，协调检查发现项整改及跟踪关闭。 Support internal audits, regulatory inspections, and external audits, coordinate remediation and closure of audit observations. 作为公司与监管机构沟通的联络人，负责符合性等相关事务的协调与沟通。 Serve as the liaison with regulatory authorities, ensuring effective communication and support for compliance-related activities. 3. 文件及数据管理Document and Data Control 建立并维护有效的文件及数据控制体系。 Maintain an effective document and data control system. 确保质量文件的起草、审核、批准、发放、修订及归档符合法规要求。 Ensure controlled issuance, revision, approval, retention, and archival of quality documents. 建立质量记录完整性、可追溯性和可获取性管理机制。Establish mechanisms to ensure record integrity, traceability, and accessibility. 负责注册文件和Artwork文件的管理，确保文件的编制、审核、批准、变更和归档符合公司质量体系及法规要求。 Own the document control process for regulatory and artwork documentation, ensuring compliance with quality and regulatory requirements. 4. 培训管理Training 建立、实施并持续完善培训体系，确保符合中国医疗器械GMP、ISO 13485及相关法规要求。Establish, implement, and continuously improve the company's training management system in compliance with China Medical Device GMP, ISO 13485, and applicable regulatory requirements. 制定并组织实施年度质量及合规培训计划。 Develop and maintain annual Quality and Compliance Training Plans. 建立并维护岗位培训矩阵（Training Matrix）和人员能力评估体系。 Maintain training matrices and competency assessment programs for all functions. 确保培训记录完整、真实、可追溯，并满足法规检查和审核要求。 Ensure training records are complete, accurate, and inspection-ready. 5. 年度报告Annual Report 负责各类年度报告的撰写及提交，并保持和监管机构的持续沟通。 Lead the preparation and submission of various annual reports and maintain ongoing communication with regulatory authorities. 6. 质量系统管理 Electronic Quality Systems Management 与总部系统负责人保持紧密合作，推动电子质量管理系统的上线和管理，确保系统顺利导入并满足业务及质量体系要求。Collaborate with Global Process Owners to support the deployment and management of the eQMS, ensuring compliance with business and QMS requirements. 7. 所有职位必须包含以下内容：All positions must include the following: 负责将业务相关问题或机会传达给下一级管理层。Responsible for communicating business-related issues or opportunities to the next level of management. 对于那些监督或管理员工的人员，如适用，负责确保下属遵循与健康，安全和环境实践相关的所有公司指南，以及所有需要的资源都是可用的，且状况良好。 For individuals who supervise or manage employees, as applicable, responsible for ensuring that direct reports comply with all company guidelines related to Health, Safety, and Environment (HSE) practices, and that all required resources are available and maintained in good working condition. 负责确保个人和公司遵守联邦、州、地方和公司的所有法规、政策和程序。 Responsible for ensuring individual and company compliance with all applicable federal, state, local, and company regulations, policies, and procedures. 执行其他必要的职责。Performs other duties as required. Required Skills: Preferred Skills: Business Savvy, Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Developing Others, Fact-Based Decision Making, Give Feedback, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Processes, Quality Standards, Standard Operating Procedure (SOP), Team Management