更新于 2026-02-05 01:26:10

QA质量工程师

9000-18000元·14薪
  • 常州新北区
  • 1-3年
  • 本科
  • 全职
  • 招1人

职位描述

二类医疗器械过程质量控制ISO13485设备验证
岗位职责:
1.识别医疗器械法规要求,保证其在生产过程的落实;
2.负责产品质量控制文件(进料检验、过程检验、成品检验)的编制与检验工作;
3.负责产品的生产过程验证、设备验证,对生产过程进行监控,对变更文件进行审核;
4.负责主导内部质量改善,包括6Sigma管理、QC小组和PPAP等为工具的各项改进活动;
5.促进产品质量提升,负责内部纠正预防措施的建立和执行。
岗位要求:
1.本科及以上学历,生物、机械或材料学等相关专业;2-3年相关质量经验;
2. 良好的团队合作和沟通能力;
3.掌握质量管理相关工具,熟悉ISO134855/YY/T0287标准,有质量改进项目管理经验。
职位福利:五险一金、餐补、定期体检、节日福利、带薪年假、周末双休、14薪

工作地点

新北区常州乐奥医疗科技股份有限公司

职位发布者

徐女士/招聘经理

昨日活跃
立即沟通
公司Logo乐奥医疗
常州乐奥医疗科技有限公司是海外归国人员创立的、致力于高端医疗器械研发、制造和销售的高科技中外合资企业。拥有具备国际视野和丰富医疗器械研发、生产、品质和销售经验的优秀团队,团队核心成员拥有多年在海外工作和国际国内领先企业从事研发、销售的经验。Leo Medical Co., Ltd. is a high-tech medical enterprise. We dedicate our work to research, develop, manufacture and market advanced medical devices. We have excellent teams of researchers, engineers, quality assurers and marketers. Many of them have extensive experience in their fields, and have collaborated with experts in various prestigious domestic and international institutions and companies in medical device development field.公司采用领先的生物医疗技术,服务于消化系统和血管循环系统疾病的诊断和治疗。公司目前已经研发的产品覆盖消化和血管介入治疗的微创医疗器械。公司秉承关注人、依赖人和服务人的理念,研发符合中国患者特点和中国医生使用习惯的医疗器械产品,为医生提供方便,为患者减轻病痛。Leo Medical utilizes leading biomedical technologies to develop medical devices for assisting the diagnosis, intervention and treatment of diseases in the digestive system and cardiovascular system. We believe in minimal invasive approach being the most human approach to the patients while not compromising the quality of the procedure. Minimal invasion in medical treatments often allow patients to recover quicker, and doctors to have simplify medical operation. It is a win-win approach for all. We stand by our believes and will continually devote our focus in this area.公司注重安全和质量,拥有符合国家质量体系标准的一万级净化车间和高品质的检测平台,确保每一件产品的质量。公司通过ISO13485质量体系认证,合乎国际质量管理体系要求。In addition to features, more importantly, we highly emphasis on safety and quality of our products. Our products are manufactured in 10,000 Class Clean Room(Equivalent to Grand B of ISO standards). We follow repeatable and practical SOPs for product testing online and offline. Leo Medical is accredited with ISO13485:2003 Certificate of Quality Management System and is in fully compliance with The Requirements of International Quality Management System.
公司主页