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Engineer, Quality

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Description

Primary Purpose: Lead design and development teams as the primary quality representative from proof of concept through design transfer. This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to ensure that products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements. 从概念论证到设计转移,作为质量代表领导设计和开发。 该员工应运用其设计控制原则和质量工程技术知识,确保产品的开发和制造符合适用的行业标准、法规要求和客户要求。

What You Will Do In Your Role

  • Draft, coordinate and maintain Customer owned Design History File (DHF) strategy and deliverables.  起草、协调和维护客户拥有的设计历史文档策略和交付成果。 
  • Be responsible for drafting and maintaining the design control procedures and supporting documentation in the Phillips Medisize Quality Management System.  负责起草和维护辉美医疗质量管理体系中的设计控制程序和支持文件。 
  • Represent Phillips as the subject matter expert in design control regulations and standards during internal and external customer activities, audits and certification activities.  在内部和外部客户活动、审核和认证活动中,代表辉美医疗作为设计控制法规和标准方面的主题专家。 
  • Write, edit, and maintain design quality plans, protocols and reports.  编写、编辑和维护设计质量计划、方案和报告。 
  • Work closely with design and development team in identifying and developing User and Stakeholder needs. 与设计和开发团队紧密合作,识别和开发用户和利益相关者的需求。 
  • Participate in writing and maintaining user needs and design input requirements.  参与编写和维护用户需求和设计输入需求。
  • Review and approve plans, protocols and reports for testing, verification, validation.  审核和批准用于测试、验证、确认的计划、方案和报告。 
  • Execute the test method development and validation efforts including identification of applicable standards and guidance, establishing criteria, and approving results.  执行测试方法的开发和验证工作,包括确定适用的标准和指导建立标准和批准结果。 
  • Take responsibility for the Risk Management Process, including integration into the design and development process and management of the risk management file.  负责风险管理流程,包括整合到设计开发流程和风险管理文档。 
  • Write, edit and maintain risk management plans/ reports and risk assessments including use of risk analysis tools (FMEA, FTA and Hazard Analyses).  编写、编辑和维护风险管理计划/报告和风险评估,包括使用风险分析工具(FMEA、FTA和危害分析)。 
  • Lead root cause analysis investigations into potential design failures or prospective design changes.  领导潜在设计失效或预期设计变更的根本原因分析调查。
  • Interface and support work as a liaison to the Quality Engineer (QE) in design changes, design transfer, design for manufacturing (DFM) and process development. 在设计变更、设计转移、制造设计(DFM)和过程开发方面,作为与质量工程师(MQE)的联络人进行接口和支持工作。
  • Extended travel to other facilities may be required to support business needs.  为配合业务需求,需要被派且至其他工厂支持。 
  • Other duties as assigned by supervisor.  其他由主管指派的任务。


The Experience You Will Bring

Requirements:

  • Education: 
  1. Bachelor degree in an engineering or technical discipline or equivalent experience (Advanced graduate degree desirable). 工程或技术专业学士学位或同等经验(高级研究生优先)。
  • Skills & Abilities: 
  1. Skilled in MSA.  MSA技能。
  2. Coaching skill.  教育训练技能。
  3. Fluent English both in written and oral.  流利的英语书写和口语。
  • Experience: 
  1. Over 3 years working experiences in quality assurance of Design & Development.  三年以上设计和开发质量保障经验。


What Will Put You Ahead

  • Education: 
  1. Experience working at or with contract manufacturing / development organizations.  在合约制造/研发工作或与之合作的经验。 
  2. Medical device product work experience desirable.  医疗器械产品工经验优先。
  3. ASQ certification desirable (CQE, CQA, etc.).  ASQ 认证优先(CQE, CQA等)。
  • Skills & Abilities: 
  1. Expertise in Quality Management System regulations and standards including ISO 13485 and 21 CFR 820 (knowledge of 21 CFR 210/211 desirable).  熟悉质量管理体系法规和标准,包括ISO 13485和21 CFR 820(熟悉21 CFR 210/211 优先) 。
  2. Thorough knowledge and understanding of EN ISO 14971 and other risk management practices.  对EN ISO 14971和其他风险管理实践有全面的了解和理解。  
  3. Knowledgeable about analysis tools as needed including SPC, GR&R, tolerance analysis (CETOL), Minitab.  熟悉SPC, GR&R,公差分析(CETOL), Minitab等分析工具。 
  4. Extensive knowledge of quality tools: risk analysis and evaluation, six sigma, DOE, lean principles, root cause analysis, problem solving approaches, reading and correcting drawings and specifications.  广泛的质量工具知识:风险分析和评估,六西格玛,DOE,精益原则,根本原因分析,问题解决方法,阅读和纠正图纸和规范。
  5. Strong interpersonal, communication (verbal and written), organizational and project management skills.  良好的人际关系、沟通(口头和书面)、组织和项目管理技能。
  6. Solving complex engineering and technical problems using a methodical and analytical approach.  运用系统分析的方法解决复杂的工程和技术问题。 
  7. Ability to motivate and influence people to achieve compliance to requirements.  具有能激励影响他人符合要求的能力。
  8. Self-motivated but committed to a team-oriented approach.  致力于团队 导向的自我激励。
  • Experience: 
  1. Over 3 years working experiences in quality assurance of Design & Development in medical device manufacturing area. 5年医疗器械制造领域的设计和开发质量保障经验。  


This job posting is no longer active.

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