Johnson & Johnson Careers

Quality Engineer

Suzhou, Jiangsu
Customer Technical Service


Job Description

Requisition ID: 1805658353W

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.
  • 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
  • Approve IQ, OQ, PQ, TMV or Software Validation.
       批准安装鉴定,操作鉴定,性能鉴定,测试方法确认和软件确认。
 
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.
       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。

Qualifications
  • A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field. Generally requires 2-4 years related experience.
        学士学位及以上,优先工程和相关技术专业。2-4年相关工作经验。
  • Experience working in both an FDA and European regulatory environment is preferred.
       同时拥有FDA及欧洲法规工作环境的优先
  • This position will require relevant experience working in manufacturing/operations.
        该职位需要生产/运营相关的工作经验
  • Experience with a proven track record of implementing appropriate risk mitigation.
       该职位需要相关的实现风险降低方面的可靠的工作经验
  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
       该职位需要相关的质量管理技术及经验,使用统计,精益,六西格玛的方法,包括测量系统分析,统计过程控制,实验设计,可靠性等。
  • Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.
        该职位需要精通岗位职责中列出的知识和经验。

Primary Location
China-Jiangsu-Suzhou
Organization
Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function
Customer Technical Service
Requisition ID
1805658353W