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Engineer, Quality


What You Will Do In Your Role

  1. Create and maintain PPAP packages—APQP, PFMA, control plan, SPC, MSA, ect., and submit to customer for approval. 创建和维护PPAP文件包,包括APQP, FMEA, 控制计划,统计过程控制,测量系统分析等,并递交给客户批准。
  2. Create all Quality plan/Inspection instruction for products, and perform the training to the responsible person. 建立物料/部件及产品的质量计划或检验规范,并培训至负责人。
  3. Create the SPC method for process control, and perform the training to the responsible person. 创建过程统计控制方法,并培训至负责人。
  4. Lead medical project process qualification, validation and verification and comply with global validation requirements. Create all the related new project validation protocol, reports and align with customer. 主导医疗项目的过程鉴定、确认和验证,并且顺从全球确认的要求。创建所有的相关项目的验证方案和报告,并且与客户保持一致。
  5. Customer compliant handing, lead root cause analysis and implement improve action and prevent action, finish 8D or CAPA report and review with customer. 客户抱怨的处理,领导根本原因的分析和实施改善动作和预防动作,完成8D报告和CAPA报告。
  6. Support plant continuous improvement/scrap reduction project. 支持公司持续改进及降低不良。
  7. Co-work with cross-function team to follow up deviation and non-conformance handling status. 协同内部团队持续追踪偏差及不合格的处理状态。
  8. Other duties as assigned by supervisor. 其他由主管指派的任务。


The Experience You Will Bring


  1. College degree.大专学历。
  2. 3 years experiences in a Quality Engineering filed in a molding, automotive or electronical company. 3年注塑,汽车或电子行业质量工程经验
  3. Knowledge in ISO9001. 良好的ISO9001质量管理体系知识。
  4. Good communication skills, fluent English both in written and oral, strong problem solving skills, the knowledge of FMEA/SPC/QC 7 tools/8D. 出色的沟通技巧,流利的英语书面和口语沟通能力,较强的问题解决能力,良好的FMEA、SPC、QC7 tools 、8D的知识。
  5. Good analytic senses. 良好的分析思维。
  6. Good computer skills, be familiar with EXCEL,WORK and Powerpoint.良好的计算机操作技巧,熟练运用EXCEL,WORD and Powerpoint。

What Will Put You Ahead

  1. Bachelor or above degree. Major in Mechanical Manufacture and Production Engineering Technology. 本科或以上学历,主修机械制造和生产工程技术。
  2. 2 years working experience in medical device or pharmaceutical manufacturer. 2年医疗制药行业的工作经验。
  3. Be familiar with the high-automation assembly and printing process.熟悉高自动化组装和印刷过程   。
  4. Knowledge in GMP/ ISO13485. 良好的GMP知识,及ISO13485质量管理体系知识。
  5. Be familiar with measurement equipments. 熟悉测量仪器方面的知识。


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