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 https://www.jnj.com
Job Function: Quality
Job Sub Function: Quality Assurance
Job Category: Professional
All Job Posting Locations: Suzhou, Jiangsu, China
Job Description:
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.
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。
Accountability 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.
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.
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.
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.
