QA Manager, Assurance China at Eurofins

The Quality Assurance Manager, Greater China, is responsible for establishing, maintaining and continuously improving the Quality Management System (QMS) across all three Eurofins Assurance business units in the Greater China cluster: Consumer Products Assurance (CPA), Food Assurance (FA), and Healthcare Assurance (HA).   This role serves as the primary point of contact for accreditation bodies (CNAS, ANAB, IOAS) and scheme owners, and ensures compliance with ISO/IEC 17065, ISO/IEC 17021, ISO/IEC 17020, ISO 9001, and all relevant certification scheme requirements. The QA Manager is also responsible for interfacing with Chinese government regulatory entities including CNCA (Certification and Accreditation Administration) and CCAA (China Certification and Accreditation Association), ensuring full regulatory compliance for certification operations in China.   Given the breadth of services (product inspection, social compliance audits, food safety certification, GxP audits, sustainability certification, GMP process certification), the QA Manager must have strong foundational knowledge in certification body operations and be able to apply quality management principles across diverse technical scopes, even where deep subject-matter expertise in every discipline is not feasible.   大中华区质量保证经理负责建立、维护和持续改进大中华区集群内欧陆质量认证三个业务单元的质量管理体系（QMS）：消费品认证（CPA）、食品认证（FA）和医疗保健认证（HA）。   该角色是认可机构（CNAS、ANAB、IOAS）和认证体系所有者的主要联系人，确保符合ISO/IEC 17065、ISO/IEC 17021、ISO/IEC 17020、ISO 9001及所有相关认证体系要求。质量保证经理还负责与中国政府监管实体对接，包括CNCA（认证认可监督管理委员会）和CCAA（中国认证认可协会），确保中国境内认证业务的全面合规。   鉴于服务范围广泛（产品检验、社会合规审核、食品安全认证、GxP审计、可持续发展认证、GMP过程认证），质量保证经理必须具备认证机构运营的扞实基础知识，并能够将质量管理原则应用于不同的技术范围。 Work Content 工作内容 1. Quality Management System (QMS) Governance Establish, implement, maintain and continuously improve the integrated QMS covering CPA, FA and HA operations in Greater China, ensuring compliance with ISO/IEC 17065, ISO/IEC 17021, ISO/IEC 17020, and ISO 9001 requirements. Manage the quality manual, procedures, work instructions, forms, and records across all business units, ensuring version control, accessibility and consistency. Develop certification rules for the existing and new programs, and ensure compliance with the certification implementation rules for each system within the respective business areas. Conduct management reviews with senior leadership on a scheduled basis and drive follow-up on improvement actions. Maintain and update the risk register for certification, inspection and audit operations.   1. 质量管理体系（QMS）治理 建立、实施、维护和持续改进覆盖大中华区CPA、FA和HA业务的综合质量管理体系，确保符合ISO/IEC 17065、ISO/IEC 17021、ISO/IEC 17020和ISO 9001要求。 管理质量手册、程序、作业指导书、表格和记录，确保版本控制、可访问性和一致性。 制定现有及新项目的认证规则，并确保各业务领域内的每个系统均符合相应的认证实施规则。 定期与高层领导开展管理评审，推动改进措施的跟踪落实。   2. Accreditation & Regulatory Affairs Serve as the primary liaison with CNAS (China National Accreditation Service for Conformity Assessment) for ISO 17065 and ISO 17021 accreditation cycles, including application, document submission, witness audits, annual assessment visits, and corrective action management. Interface with CNCA (Certification and Accreditation Administration) on certification implementation rules and regulatory filings, certificate maintenance by the certification body, scope extensions, and compliance with Chinese regulations governing certification activities. Maintain awareness of CCAA (China Certification and Accreditation Association) requirements for auditor registration and professional development. Coordinate with international accreditation bodies (ANAB, IOAS, UKAS) and scheme owners (GFSI schemes, GOTS, Textile Exchange, GRMA, SSCI, EXCiPACT, etc.) for accreditation/approval maintenance. Prepare for and manage external assessments, surveillance visits and witness audits.   2. 认可与监管事务 作为CNAS认可的主要联系人，负责ISO 17065和ISO 17021认可周期资质的申请、文件提交、见证审核、年度评审访问和纠正措施管理。 与CNCA对接认证实施规则监管备案、认证机构批准证书维护注册、范围扩展及中国认证活动法规合规。 关注CCAA审核员注册和专业发展要求。 与国际认可机构（ANAB、IOAS、UKAS）和体系所有者协调认可/批准的维护。   3. Internal Audit & Management Review & Corrective Action Programme, Plan, coordinate and execute the annual internal audit programme and management review across all BUs, ensuring coverage of all accreditation/certification scheme requirements. Manage non-conformity tracking, root cause analysis, corrective actions and verification of effectiveness. Facilitate office audits and process audits at operational level.   3. 内部审核, 管理评审与纠正措施计划。 规划、协调和执行覆盖所有业务单元的年度内部审核计划。 管理不符合项跟踪、根本原因分析、纠正措施及效果验证。   4. Auditor / Inspector Competency Management Oversee the competency management framework for auditors and inspectors across all BUs, including initial qualification, ongoing monitoring, calibration, witness audits, and re-qualification. Ensure compliance with APSCA requirements for social compliance auditors, CCAA requirements for food/management system auditors, and scheme-specific auditor qualification criteria. Maintain auditor qualification records and manage the annual training programme.   4. 审核员/检验员能力管理 监督所有业务单元审核员和检验员的能力管理框架，包括初始资格认定、持续监控、校准、见证审核和重新资格认定。 确保符合APSCA、CCAA和体系特定的审核员资格要求。   5. Impartiality & Ethics Management Ensure the integrity of impartiality policies and conflict of interest management across all certification, inspection and audit activities. Support the impartiality committee operations where applicable. Manage ethics reporting mechanisms and investigate complaints related to impartiality.   5. 公正性与道德管理 确保所有认证、检验和审核活动的公正性政策和利益冲突管理的完整性。   6. Complaints, Appeals & Incidents Manage the complaints and appeals handling process in accordance with accreditation and scheme requirements. Coordinate incident reporting to scheme owners and accreditation bodies when required. Ensure timely resolution and documentation of all quality-related complaints.   6. 投诉、申诉与事件管理 管理投诉和申诉处理流程，确保符合认可和体系要求。 必要时向体系所有者和认可机构协调事件报告。   7. Continuous Improvement & KPI Reporting Define, monitor and report quality KPIs (e.g., NC rates, CAPA closure times, accreditation findings, customer satisfaction scores, auditor calibration results). Drive continuous improvement initiatives across BUs and benchmark against global Eurofins Assurance quality standards. Participate in global quality meetings and align with corporate quality policies. Monitor the entire certification process, identify gaps and deviations in the process, and propose corrective and optimization measures; manage risks by identifying operational, certification impartiality, and compliance risks, and conduct regular risk assessments.   7. 持续改进与KPI报告 定义、监控和报告质量KPI（如不符合项率、CAPA关闭时间、认可发现、客户满意度、审核员校准结果）。 推动跨BU的持续改进计划，参与全球质量会议。 认证全过程监督，识别认证过程漏洞、流程偏差，提出整改优化要求；风险控制，识别经营、认证公正性、业务合规风险，定期开展风险评估   8. Additional Duties 其他职责 Perform other tasks as assigned by the Cluster Manager to support business objectives. • 完成集群经理分配的其他任务，以支持业务目标。