Business Improvements 业务改进

• Lead or support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.

主导或支持质量改进活动，对产品/制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

工具和程序。

• Conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality.

通过与外部公司或内部研究中心标杆管理开发更有效的质量管理方法提升质量。

• Establish metrics that are leading and lagging indicators of quality.

建立质量相关的领先和滞后指标的度量标准。

• Supports the development of quality engineering, quality compliance, quality leadership talents with the right skills sets for new product introductions, and product life cycle management.

支持质量工程、质量合规、质量领导人才的发展，为新产品的导入和产品生命周期管理提供正

确的技能。

• Establish Quality cost categories and Quality cost bases.

建立质量成本类别和质量成本的基础。

Compliance/Regulatory合规/法规

• 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过程是否合规，比如QSRs，ISO13485等法规要求

• Champions compliance to applicable Global Regulations and standards (e.g. China GMP, QSRs, ISO, EN and MDR 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(例如中国GMP, QSRs, ISO, EN和MDR要求)。

• Conduct periodic line audits to assess adequacy of production controls such as lot segregation. Review results of area audits to ensure that corrective and preventive actions are adequate.

执行周期审核以评估生产控制的适当性，例如批次隔离。评审区域审核的结果，确保纠正和预防措施是充分的。

Financial 财务

• Establish and maintain department/cost center budget.

建立和维护部门/成本中心预算

New Product/Process Introduction 新产品/过程导入

• 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 the development of quality strategies related to the transfer of products, materials and components within J& J or externally. Supports new product introduction as part of design transfer.

支持强生内部或外部的产品、材料和部件的转移相关的质量策略的开发。作为设计转移的一部分，支持新产品导入。

People 人员

• Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others (including Quality Engineers and Technicians).

为他人提供监督、指导、辅导、绩效评审、发展计划和继任计划（包括质量工程师和技术员）。

Product Quality, Control & Disposition and Performance Standards 产品质量、控制与处置和性能标准

• Lead and maintain Material Review Board.

领导和维护材料评审委员会。

• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.

对NC、CAPA和客户投诉进行调查、确定范围、记录、评审和批准。适当时升级质量问题。

• 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.对物料标识、材料隔离、缺陷类型分类承担责任和发挥主导作用，包括在日常生产中成功应用这些技术。
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

分析/评审纠正和预防措施的有效性。根据确定的过程评审根本原因调查的有效性。

• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.

公司的质量指标承担责任和发挥主导作用，包括维护和评审质量相关的领先和滞后指标。

Product/Process Qualification 产品/过程确认

• Approve IQ, OQ, PQ, TMV or Software Validation.

批准安装鉴定、操作鉴定、性能鉴定、测试方法确认、软件确认。

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.

与强生全球供应链、成品和材料供应商合作，以确保过程确认、过程控制、风险管理和失效的调查/纠正的适当应用。

• Conduct stakeholder analysis to ensure that customer CTQs are known and adequately addressed in control plan.

进行利益相关方分析，确保客户关键质量特性得以广泛沟通，并在控制计划中充分的处理。

• Develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes.

为生产过程开发测量系统/能力、破坏性测试、非破坏性测试。

• Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.

创建控制计划保证质量系统可控，包括产品标识，潜在缺陷类型，缺陷频次，严重度，病人风险，过程能力，过程控制等。

• 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。

• Ownership of test method qualifications.

测试方法鉴定的所有者。

• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. Standardize and develop methods/techniques of analytical/statistical analysis and interpretation. These may include descriptive, graphical, gage R& R/measurement system, reliability, capability, control chart analysis, confidence intervals, hypothesis testing, analysis of variance, design of experiments, etc.

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。规范和开发分析/统计分析和解释的方法/技术。这些可能包括描述性的、图形化的、计量器具R& R/测量系统、可靠性、能力、控制图分析、置信区间、假设检验、方差分析、实验设计等。

• 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。

• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.

监督和完成生产制造中各种类型的质量抽样计划，包括可接受性的产品分类、潜在缺陷类型、缺陷频率、严重程度、患者的风险、过程能力、过程控制等。也负责评估、应用和解释相关的生产数据的验收抽样标准。

• 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、证明、评审或分析相关过程变更在某些方面是否不会以超出当前控制能力的方式增加了风险等级，或者相关过程变更是否会导致潜在的不合规，例如QSRs。

• 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.

评估风险消减的技术支持，包括产品分类、潜在缺陷类型、缺陷发生频率、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。

• Ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes.

风险评估过程的所有权和责任，包括执行、记录、审查或维护当前风险和危害分析文件，如产品/过程变更的过程FMEA。

Strategic 战略

• Collaborates with other quality leaders to identify required quality engineering skills and competencies to allow for the execution of the strategic vision.

与其他质量主管合作，确定所需的质量工程技能和能力，以实现战略愿景。

• Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation.

与公司领导和产品工程团队进行战略规划。与其他职能合作以确定业务重点和资源分配。

• Ensures effective quality strategies are created for the validation of test methods, process and design.

确保建立有效的质量战略，包括测试方法、过程和设计的确认。

Location

• This position may require up to 30% travel and will be based in an MD manufacturing facility.