Business Improvements 业务改进 § Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. 支持质量改进活动，对产品/ 过程进行持续改进和成本改善。 § Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. 评估和分析质量工具及项目的有效性，比如 PDCA，六西格玛，改善，精益技术和/ 或其他改进工具。 § Conduct benchmarking to develop more effective methods for improving quality. 通过标杆管理开发更有效的质量管理方法提升质量。 § Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. 开发合适的质量管理方法应用于质量工程和质量合规的发展，运用在新产品导入和产品生命周期管理。 Compliance/Regulatory 合规管理 § Review/analyze whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc. 评估和分析现有产品和制程是否合规，比如 QSRs， ISO13485 等法规要求 § Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits. 支持工厂的内外部审核，遵守适用的法规和标准( 例如 QSRs, ISO, EN 和 MDD) 要求。 § Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate. 执行周期审核评估生产现场是否合规。审阅区域审核的结果确保纠正和预防措施有效。 New Product/Process Introduction 新产品/ 制程导入 § Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. 协调研发和其他的跨部门合作确保相关领域质量管理可控。比如设计管理，风险管理，研发失效的调查/ 纠正等方面。/ § Supports new product introduction as part of design transfer. 支持新产品导入业务活动，作为研发项目转移的一部分。 Product Quality, Control & Disposition and Performance Standards 产品质量控制处理和执行 § Supports activities related to the Material Review Board. 支持材料审核相关业务活动 § Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. 执行 NC， CAPA 和客户投诉的调查分析，审阅和批准。 § Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing. 监督和处理生产现场日常发生的问题，比如材料标识、物料隔离、缺陷分类等。 § Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. 分析审阅纠正预防措施的有效性。根据确定的过程审核根本原因调查的有效性。 § A ccountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality 监督和完成公司的质量指标，包括维护和检查质量相关的领先和滞后指标。 Product/Process Validation 产品/ 过程确认 § Initiate, review, approve, execute validation or verification documents, such as IQ, OQ, PQ, TMV, Software Validation documents etc., as the engineer/representative/lead/SME of Process Validation/CSV/CSV-E according to the arrangement of work. 根据工作安排，作为过程确认、 CSV、 CSV-E 的工程师、代表、组长或者主题专家，起草、评审、批准和/ 或执行确认/ 验证文件，例如安装鉴定、操作鉴定、性能鉴定、测试方法确认、软件确认等文件。 Production/Process Controls including Control Plans 产品/ 过程控制包括控制计划 § Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed. 协调与沟通强生全球供应链合作伙伴, 成品和材料供应商, 以确保所有的质量业务活动满足要求，比如过程验证，过程控制，风险管理，过程失效的调查/ 校正过程。 § Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. 开发、解释和实施适当的过程监视和控制方法与过程/ 产品风险的水平一致 § Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. 收集数据和执行进行各种分析/ 统计分析和指导，作为过程改善和日常工作支持的一部分。 § Develop, interpret and implement standard and non-standard sampling plans. 开发、解释和实施标准和非标准的抽样计划。 § Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis. 评估测量系统的有效性。包括测量工具, 破坏性测试, 非破坏性测试, 测量系统分析。 § Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits. 评估和分析生产制造中普通和特殊原因的变异，并确定合适的制程控制临界点。 Risk Mitigation 降低风险 § Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs. 记录, 说明, 审核或分析相关过程变更在某些方面是否增加了风险等级，或者相关过程变更是否会导致潜在的不合规。 § Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements. 评估风险降低的技术支持，包括产品分类，潜在缺陷类型，缺陷频率，严重度，患者风险，过程能力，过程控制等。确定之前已经实现改善的技术支持的有效性。 Strategic 战略 § Ensures effective quality strategies are created for the validation of test methods, process and design. 确保有效的质量战略建立，包括测试方法，过程和设计的验证。 **Qualifications** § In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. 精通产品/ 过程风险管理方面的知识(FDA 和 ISO 标准)。 § Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making. 精通统计技术方面的知识。有能力预览，制图，分析数据并能够展示促进和决策。 § The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired. 有能力独立分析解决处理问题。有能力实地思考并提供可靠的判断决策能力。 § Good technical understanding of manufacturing equipment and processes is required. 熟悉生产设备和过程管理技术 § Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. 了解新产品导入和过程确认经验者优先。 § A thorough understanding of GMP/ISO regulations and validation regulations is preferred. 精通 GMP/ISO 法规条例优先。 § Demonstrated project management and project leadership abilities are preferred. 要求具备项目管理和项目领导的能力优先。