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品质工程师QA Engineer(体系) No.4285321

7-8K
品质部|
1人|
广东东莞
|6小时45分钟前刷新
学历要求
大专
工作经验
3年
年龄要求
22-40
现居住地
东莞
岗位职责Job Responsibility:
1.Support to valid and track CAPA effectiveness 协助QA 对CAPA有效性的验证及跟踪
2. Suppot to implement and maintain NMPA and QMS related paperwork 协助QA 做相关的NMPA 推行及维护, 及QMS的相关的文书工作
3. Support to improve and follow up the quality project, organize and make the corresponding corrective action, track and verify its effectiveness 协助QA对品质专案的改进与跟踪,组织并制定相应的纠正措施,跟踪验证其有效性
4. Suppor to do internal and external audit of ISO9001&ISO13485 system and follow up the unqualified item and implement NMPA 协助QA做ISO9001&ISO13485 体系内外审及不合格项追踪和推行NMPA.
5. Advance quality planning of medical products and follow-up of improvement measures
医疗产品的先期品质策划及改善措施的跟进
6. Support to collect statistic related quality data and determine improvement direction
协助收集统计相关的品质数据,确定改善的方向
7. Support to make advance quality plan and FMEA for new products.
协助QA做新产品的先期品质计划及FMEA.
8. Support to regularly audit medical product manufacturing process compliance and re-evaluate product risk
协助对医疗产品制程合规性的定期审核及产品风险的再评估
任职资格Job qualification:
1. College degree or above in product quality Engineering, biomedical engineering or related major; Basic English, good at reading and writing
大专以上学历,产品质量工程、生物医学工程或相关专业,有一定英语基础,读写良好
2. be Familiar with ISO13485 , GMP and internal auditor qualification certificate for pirority.熟悉 ISO13485、GMP 等质量管理体系,有内部审核员资格证优先
3. Have the quality control management experience in medical device manufacturer prefer
有医疗器械制造 的质量控制管理经验者佳。
4. Skilled in quality tools, such as quality 7 tools, MSA, FMEA, SPC, CP, 8D, 5WHY, fish bone diagram, etc., familiar with problem processing process。熟练使用质量工具,如质量7个工具, MSA, FMEA, SPC, CP, 8D, 5WHY, fish bone diagram等,熟悉问题处理流程。
7513 1513-9|165 6665 5462 245. Be interesting in office copy and documents management.对办公室文案和文件管理有兴趣
职位晋升:
  • 品质工程师QA Engineer(体系)
  •  
  • 品质工程师
  •  
  • 高级品质工程师
工作地址:
广东东莞常平镇桥梓村环城路口 (澳思对面) 查看地图
面试地址:
广东东莞常平镇桥梓村环城路口 95号
职位标签:
体系 ; 系统 ; 品质 ; 品质体系
职位类别:
体系工程师
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