DHR Reviewer Leader
Found in: beBee S CN - 4 weeks ago
DHR Reviewer Leader - 00001KLA
Description
§ Responsible for routine Device History Records (DHR) review. During DHR review, if any deviation is found, return to originator for correction or related QE for evaluation;/ 负责日常器械历史记录的审核。任何错误退回相关人员纠正或获得评估。
§ Ensure the completed DHR meet all GMP/ MDD requirements after review;/确保审核后的器械历史记录完整，满足GMP和医疗器械的要求。
§ Ensure product is released properly and timely after DHR review, and issue certificate of conformance if required. /确保产品在审核后被正确的、及时的放行，需要时发放一致性证书。
§ Execute final inspection activities as required for China market products as per CFDA requirements；/ 需要时根据CFDA要求针对中国市场产品执行最终检验。
§ Responsible for trends analysis for failure mode of DHR review and improve DHR performance; /负责器械历史记录审核结果的趋势分析和失效模式分析，改善器械历史记录的业绩。
§ Responsible for the timely filing of the completed DHRs. / 负责定期完成器械历史记录的存档。
§ Responsible for DHR reviewer resource analysis and take action to meet product release requirement;/ 负责器械历史记录审核人员资源分析并且采取措施以满足产品放行要求。
§ Work closely with Quality engineering, QA and operation to finish DHR error evaluation and affected product disposition in time; /与质量工程、质量保证、生产密切工作，完成器械历史记录错误的评估和及时处置受影响产品。
§ Maintain finish product information in SAP before product release;/产品放行前在SAP内维护成品信息。
§ Perform the DHR review tasks during the shortage period；/ 在团队时间紧张期间执行器械历史记录审核工作。
§ Collect data and maintain dashboard；/ 数据收集和报表维护。
§ Drive the ownership , accountable and improvement philosophy in the team;/ 在团队中推动主动性，负责任的，以及不断改善的工作哲学。
§ Perform or organize internal / GMP audit if required. /根据需要执行或组织内审或GMP审核。
§ Lead improvement in specific area ; Support other team for the improvement activities；/ 在特定区域主导改善；支持其他团队的改善行动。
§ Maintain good working climate. 维持良好的工作氛围。
§ Maintain & improve the relationship with cross function; / 维护，改善与其他工作团队的关系。
§ Assurance team achieve the operation and quality target ; / 保证团队达成运营和质量目标。
§ As a guide, take initiative activities base on the needs from both internal or external customer in daily work; /作为一个指导，在日常工作中根据内外部客户的需求采取主动性行动。
§ Responsible for minimizing both the Environmental and Health & Safety effects of the work that DHR team performed; / 负责将器械历史记录审核团队工作时对环境、健康、安全方面的影响最小化。
§ In accordance with DePuy-Synthes Worldwide Quality strategy, participate to the development of the quality system and its day to day implementation: Participate in training or workshop to deploy the Quality philosophy based on FDA QSRs, ISO 13485 and CFDA requirements; Ensures compliance to all GMPs and MDD requirements; Perform all job duties in full accordance with: The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information; All J&J policies and local regulations; The policies of the Health Care and Environmental programs; The code of conduct policies. 按照DePuy-Synthes全球质量策略，参与质量体系的开发和日常的执行：根据FDA, QSRs, ISO 13485 和CFDA的要求参与培训或车间研讨会以贯彻质量哲学；确保满足GMP和医疗器械合规方面的要求。执行所有工作职责时参照：强生信息管理、资产管理、密码保密性、保护公司关键信息方面的政策；所有强生政策和本地法规；卫生保健健康和环境项目的政策；行为规范方面的要求。
§ Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…). /与其他所有员工一样，对所有审核 (内部，公司，外部的质量，环境，健康安全) 负责。
§ Perform other work assigned by supervisor. /执行主管指派的其他工作。
Qualifications
§ Team work and communication skill/团队工作/沟通技能
§ Risk analysis ability / 风险分析能力
§ Continuous and versatile learning ability/ 持续和全面的学习能力
§ Good GMP and ISO13485 quality system knowledge / 优秀的GMP和ISO13485质量体系方面的知识
§ Computer literacy skill/ 计算机能力
§ Written and verbal English skill / 英语书写和口头沟通能力
§ University degree or above/ 大学学位或以上
§ 4 years or above working experiences related to quality in medical devices/Pharmaceutical plant/4年以上制药或医疗器械制造公司的质量相关经验
§ Self-inspiring ability; / 自我激励能力
§ Sense of urgency & efficiency; / 紧急性和效率方面的意识
§ Ability to Work under pressure; / 压力之下工作的能力
§ Well-developed organizational skills, / 优秀的组织能力
§ Ability to work on own initiative； / 基于自身推动的工作主动性
§ Influencing & leadership ability；/ 影响力和领导力
§ Statistics knowledge and application；/ 统计知识应用
§ Resource analysis & planning ability ；/ 资源分析和计划能力
Primary Location Asia Pacific-China-Jiangsu-Suzhou
Organization Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function Quality Control
Req ID: 00001KLA
