仪器质检工程师
深圳市伯劳特生物制品有限公司
- 公司规模:50-150人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-11-27
- 工作地点:深圳-南山区
- 招聘人数:2人
- 工作经验:2年经验
- 学历要求:大专
- 职位月薪:6-9千/月
- 职位类别:医疗器械生产/质量管理 医疗器械维修人员
职位描述
1.负责原材料、制程、半成品、组件、成品的检验控制及生产车间的品质监控和督导;
2.参与不合格品的判断及评审,并负责产品检验状态的标识;
3.参与制定物料的质量控制点和产品检验标准,并按检验标准完成检验工作;完善质量控制手段与技术方法;
4.负责质量部质量记录、设备档案等的填写、归档、整理工作。
任职资格:
1..电子、机械、自动化等相关专业, 有 2 年以上相关行业质量检验经验;
2. 熟悉基础质量控制知识、具有较强的质量意识和责任感、实事求是、能承担一定的工作压力;
3. 熟悉有源器械生产物料(电子元器件/塑胶件/机加件/钣金件/PCB板卡/线材等物料)检验规范与工作流程;
4. 知晓医疗器械法律法规,如ISO 13485、《医疗器械生产质量管理规范》等。
有质检员上岗证、内审员证优先.
公司介绍
深圳市伯劳特生物制品有限公司成立于1999年1月,是国家及深圳市认定的高新技术企业。公司成立之日起就致力于从事免疫印迹诊断试剂的研发和产业化,拥有按照国家体外诊断试剂生产管理法规要求建立的十万级别净化车间、现代化实验室、仓库物流库房,购置了现代化的实验、检测和生产设备,先后获得国家医疗器械生产许可、经营许可及德国TUV莱茵公司ISO13485:2003质量体系。2007年,公司合作项目《幽门螺杆菌关键治病因子CagA、VacA的生物特性及其临床应用》荣获国家科学技术进步二等奖(证书号:2007-J-233-2-01-R08)。目前,公司拥有糖尿病自身抗体免疫印迹试剂盒(免疫印迹法)、风湿病自身抗体免疫印迹试剂盒(免疫印迹法)、幽门螺杆菌抗体分型检测试剂盒(免疫印迹法)、风湿病自身抗体检测试剂盒(斑点印迹法)等多个自主知识产权产品,其中,幽门螺杆菌抗体分型检测试剂盒(免疫印迹法)获得2012年度科技部科技型中小企业技术创新基金立项支持。
公司注重知识产权领域的保护,目前已拥有发明专利四项(改良罗氏快速培养基及其制备方法: ZL 2008 1 0099812.0,一种用于糖尿病自身抗体6项联检试剂盒: ZL 2012 1 0486571.1,降钙素原检测试纸条及其制备方法:ZL 2012 1 0498784.6 ,一种幽门螺杆菌分型检测的试剂盒:ZL 2015 1 0033662.3),在申请并已进入实审阶段发明专利三项。
2015年度,我司实现年产销各类诊断试剂逾10万盒,客户涵盖各等级医疗机构、科研机构、专业体检机构和第三方检测机构,市场辐射全国各大主要城市,继续保持较为高速的增长势头,并逐步形成了集自主研发、生产、销售体外诊断试剂为一体的完整产业链。
Founded in 1999, Shenzhen Blot Biological Products Co., Ltd. is a national high-tech enterprise specializing in the research, development and production of in vitro diagnostic reagents. The company is headquartered in Shenzhen and has R&D facilities in the United States. The company relies on years of technical reserves, and cooperates with professional institutions and experts to build a multi-directional, multi-platform, multi-variety IVD product development and production system; the company had completed the basic research project: "Helicobacter pylori key pathogenic factor CagA, VacA and clinical application” , which show VacA and CagA are key pathogenic factors of Helicobacter pylori. The contribution had been granted he second prize of National Science and Technology Progress Award; Our main products: “Helicobacter pylori antibody typing test kit” (immunoblotting) not only confirms the presence of Helicobacter pylori infection, but also further evaluates the virulence and pathogenicity of bacteria, helping clinical precision diagnosis and treatment and avoiding over-medical treatment. Such product finally contribute the rational allocation of medical resources , the deterioration of antibiotic resistance of Helicobacter pylori, and significantly benefit health, economic..
公司注重知识产权领域的保护,目前已拥有发明专利四项(改良罗氏快速培养基及其制备方法: ZL 2008 1 0099812.0,一种用于糖尿病自身抗体6项联检试剂盒: ZL 2012 1 0486571.1,降钙素原检测试纸条及其制备方法:ZL 2012 1 0498784.6 ,一种幽门螺杆菌分型检测的试剂盒:ZL 2015 1 0033662.3),在申请并已进入实审阶段发明专利三项。
2015年度,我司实现年产销各类诊断试剂逾10万盒,客户涵盖各等级医疗机构、科研机构、专业体检机构和第三方检测机构,市场辐射全国各大主要城市,继续保持较为高速的增长势头,并逐步形成了集自主研发、生产、销售体外诊断试剂为一体的完整产业链。
Founded in 1999, Shenzhen Blot Biological Products Co., Ltd. is a national high-tech enterprise specializing in the research, development and production of in vitro diagnostic reagents. The company is headquartered in Shenzhen and has R&D facilities in the United States. The company relies on years of technical reserves, and cooperates with professional institutions and experts to build a multi-directional, multi-platform, multi-variety IVD product development and production system; the company had completed the basic research project: "Helicobacter pylori key pathogenic factor CagA, VacA and clinical application” , which show VacA and CagA are key pathogenic factors of Helicobacter pylori. The contribution had been granted he second prize of National Science and Technology Progress Award; Our main products: “Helicobacter pylori antibody typing test kit” (immunoblotting) not only confirms the presence of Helicobacter pylori infection, but also further evaluates the virulence and pathogenicity of bacteria, helping clinical precision diagnosis and treatment and avoiding over-medical treatment. Such product finally contribute the rational allocation of medical resources , the deterioration of antibiotic resistance of Helicobacter pylori, and significantly benefit health, economic..
联系方式
- Email:2799940246@qq.com
- 公司地址:地址:span月亮湾大道2076号中国高科大厦D座六楼