Staff Engineer, Supplier Quality

KEY RESPONSIBILITIES / DUTIES主要职责:

• Own Supplier related CAPA review and management ensuring effective use of appropriate problem-solving tools.
• 负责供应商相关的纠正预防措施的评审和管理确保有效使用合适的问题解决工具
  Support tracking and reporting of KPI and other metrics associated with supplier performance.
• 支持KPI和其他与供应商绩效相关的指标的跟踪和报告
  Provide education and training to suppliers as necessary.
• 向供应商提供必要的教育与培训
  Articulate detailed supplier performance results and trends to appropriate levels of management.
• 向管理层详细说明供应商业绩评估结果与趋势
  Performs PPAP activities for supplier changes
• 执行供应商变更的PPAP相关措施
• Perform detailed process reviewsat suppliers manufacturing site.
• 在供应商的生产现场进行详细的工艺评审
• Assess and critique supplier process control documentation identifying areas of improvement and driving improvement within the suppliers QMS.
• 评估和评判供应商的过程控制文件识别需要改进的区域并推动供应商的质量管理体系的改进
• Communicate effectively to suppliers and internal stakeholders.
• 与供应商和史赛克内部利益相关者建立有效的沟通
• Maintain and track to completion closure of assigned supplier action items.
• 维护并跟踪所分配的供应商措施项目的完成情况
• Collaborate with external/internal teams and stakeholders to prioritize supplier initiated change requests.
• 与外部/内部团队和利益相关者合作优先处理供应商提出的变更请求
• Develop and drive completion of personal development plans (IDP).
• 制定并推动个人发展计划的完成
• Support PMO projects and initiatives.
• 支持PMO项目和计划
• Develop relationships wtih suppliers and internal cross functional partners.
• 发展与供应商和内部跨部门合作伙伴的关系
• Identify and execute on cost reduction opportunities through quality improvements at suppliers.
• 通过供应商的质量改进来发现并执行降低成本的机会
• Manage and executesupplier initiated changes for continuous improvement cost reduction or supplier remediation activities.
• 管理和执行供应商发起的变更以持续改进降低成本或供应商整治措施
• Analyzenon-conformance data to prioritize projects and to solve systemic supplier issues.
• 分析不符合项数据确定项目的优先级解决系统供应商问题
• Executepro-active supplier site visits.
• 积极主动地执行供应商现场访问
• Transferlessons learned from the supply base back to R&D for incorporation into next generation designs.
• 将从供应商处获得的经验教训传达给研发部门用于下一代产品设计
• Provide problem solving expertise at supplier locations in support of critical quality issues.
• 为供应商提供解决问题的专业知识以支持关键的质量问题的解决
• Train mentor and assist in the development of less experienced engineers.
• 培训指导和协助缺乏经验的工程师的发展
• Propose and develop effective quality improvement plans to be implemented at appropriate suppliers.
• 对合适的供应商提出并制定有效的质量改进计划并加以实施
• Provide support to 3rd Party Audits relating to Supplier Quality CAPA.
• 协助第三方审核供应商质量问题相关的CAPA
• May act as a single point of contact for Strategic Business Partners and in some cases for Strategic Suppliers.
• 可以作为战略商业伙伴以及某些情况下的战略供应商的单点联络窗口
• Serveas a subject matter expert for assigned commodity; share expertise within global Stryker organization.
• 担任指定商品的专家; 在全球Stryker组织中分享专业知识
• Lead or Oversee project portfolio of supplier improvement activities.
• 领导或监督供应商改进活动的项目专案组合
• Collaborate with external/strategic partners to identify companywide opportunities for supplier improvement.
• 与外部/战略合作伙伴合作识别整个集团范围内的供应商改善机会
• Oversee processes as a process owner and drive standardization of SQ-related processes such as PPAP DPM etc
• 作为责任人监督整个工艺过程并推动与质量标准相关的过程的标准化如PPAPDPM等

SUPERVISORY RESPONSIBILITIES管理职责:

• Serve as a liaison between suppliers and Stryker to drive effective continuous improvement to the supplier base. Work with internal customers and suppliers to support supplier quality issues provide technical support for activities related to supplier quality system assessment and performance evaluation. Collaborate with the strategic sourcing auditing and development groups to understand the capabilities and competencies of suppliers to fulfill product quality and regulatory requirements.
• 作为供应商和Stryker之间的联络人有效地推动供应商的持续改进与内部客户和供应商合作以解决供应商质量问题为供应商质量体系评估和绩效评估提供技术支持与战略采购审计和开发团队合作了解供应商的自身能力和核心竞争力以满足产品质量和法规要求

REQUIRED SKILL SET岗位技能

• Good knowledge with GMP ISOCFR Part 820 standards

• 了解GMP ISOCFR Part 820方面的标准
• Working knowledge of FMEA Validation Programs and SPC processes in a highly regulated environment
• 在高度监管的环境下有失效模式分析验证程序以及统计过程控制等工作经验
• Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality
• 了解Lean工具以及理念有实际运用lean理念来改善整个生产制造质量表现的能力
• Demonstrated working knowledge to influence positively the trend of the relevant supplier quality metrics.
• 有让供应商质量指标朝着正向发展的工作经验
• Strong analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions
• 较强的分析解决问题的能力能快速洞察数据背后的因素并制定可执行的措施
• Ability to plan organize and implement multiple concurrent tasks
• 能够同时策划组织并执行多种不同任务
• Strong communication skills. Must demonstrate the ability to communicate up/down and across different levels of the organization.
• 较强的沟通技巧必须证明有能力与组织的上下不同阶层进行有效沟通
• Demonstrated ability to work in cross-functional team environments
• 有实际跨部门协作的经验能力
• Willing to travel in support of business needs to different geographical locations.
• 愿意根据业务需求去不同地方/国家支援史赛克分公司

RELEVANT EXPERIENCE

经验要求

• Experience in a highly regulatory environment desirable. 有高度管制环境的工作经验
• Working knowledge of FMEA validation programs and SPC processes.
• 熟悉FMEA验证程序和SPC流程
• Strong understanding of manufacturing prints and tolerancing.
• 对图纸和公差有深刻的理解
• Working knowledge in statistics.
• 有统计学相关知识
• Strong interpersonal skills written oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
• 较强的人际交往能力书面口头沟通和谈判技巧必须证明能够有效地在组织的不同级别上/下进行沟通
• Working knowledge and understanding of manufacturing processes.
• 对生产制造流程的有相关知识并理解
• Thorough knowledge and understanding of US and International Medical Device Regulations.
• 对美国和国际医疗器械法规有全面透彻的理解
• Good understanding of project management.
• 对项目管理有较好的理解
• Demonstrated working knowledge to positively influence supplier quality performance.
• 具备积极影响供应商质量绩效的工作知识
• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.
• 具有分析和解决问题的能力能够快速从数据中获取见解并定义可执行的操作
• Demonstrated ability to work in cross-functional team environments.
• 具有在跨职能团队环境中工作的能力
• Ability to plan organize and implement multiple concurrent tasks.
• 能够计划组织和执行多线程任务
• Good knowledge of continuous improvement methodologies.
• 熟悉持续改进方法
• Good knowledge of lean tools and concepts. Demonstrated the ability to apply lean concepts throughout a manufacturing operation to improve quality.
• 熟悉精益工具和概念能够在整个生产过程中应用精益理念以提高生产和产品质量
• Computer literacy.
• 电脑使用能力
• Travel required.
• 需经常出差

EDUCATION

教育背景

• BSc / B. a science engineering or related discipline preferred or equivalent years of experience.
• 理学士/工程理工科或相关专业优先或同等年限工作经验
  ASQ CQE/CMQ/OE/PE certification preferred.
• 有ASQ CQE/CMQ/OE/PE认证者优先
• Lean Six Sigma green certification preferred.
• 精益六西格玛绿色认证优先
• Minimum of 5 years experience in manufacturing environment or equivalent preferred.
• 5年以上制造业工作经验或同等工作经验优先
• Lead Quality Auditor Qualification preferred (ISO 13485 CFR 820 or comparable industry standard and regulatory requirements).
• 具有ISO 13485 CFR 820或相关行业标准和法规要求的主任审核员资格优先