生产经理
苏州信迈医疗器械有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2014-07-17
- 工作地点：苏州
- 招聘人数：1
- 学历要求：本科
- 职位月薪：面议
- 职位类别：医疗器械生产/质量管理
职位描述
1.负责设备的采购、安装及调试。担任设备管理工作，负责质量管理体系和设备及厂房设施的管理，包括无菌医疗器械生产企业净化区域设施、环境调控运作，净化区域环境的测试方法；负责ISO9002质量体系及CE认证工作。负责ISO9002质量体系及CE认证中设备及洁净环境方面所有的二级及三级文件的编制和培训。
2.负责设备组、机电组的工作计划、目标的制定、人员管理、基础设施费用预算、核算。保证水、电、气的正常供应以及制造设备的正常运转。
3.参加和负责生产工艺的研发、洁净车间建设、生产及基础设施的日常管理，以GMP标准负责临床产品的生产。
4.担负公司主要负责人和董事会赋予的任务。
岗位要求：
1.本科毕业或本科以上学历
2.必须有实际操作过一个植入三类医疗器械报批全过程的工作经历
3.熟悉医疗器械SFDA日常监管要求
4.良好的沟通、协调能力及团队精神，思路清晰，条理性强
5.较强的独立处理问题和日常业务决策能力
6.无药品或医疗器械行业经验者勿投！
公司介绍
苏州信迈医疗器械有限公司是一家成立于苏州生物纳米园的创新型医疗器械研究公司，专注于开发产具有准确标测肾神经功能的消融导管及配套射频消融仪，用以治疗高血压及相关的心血管疾病。基于公司获美国crt2012***创新奖的多项专利技术，信迈革命性的创新产品将解决当前临床上无法定位肾交感神经、疗效及安全性低下的难题，使去肾神经技术和器械进入一个新的时代。信迈的优秀团队涵盖了介入器械研发的各个环节，具有生物生理学、药理病理学、医学机械电气工程学、电生理介入手术和知识产权等方面的深厚造诣，并拥有业界的广泛人脉和丰富的成功创业经验。
suzhou symap medical ltd is located at suzhou biobay as an innovative medical device company. the company is founded by an excellent team with outstanding reputation and exceptional experience in cardiovascular medical device field in both china and us. symap is dedicated to developing a proprietary catheter-based renal mapping and ablation system for renal denervation therapy to treat hypertension and other diseases, such as heart failure, arrhythmia, renal failure, diabetics and sleep apnea, etc. our novel renal mapping and ablation technology optimizes the delivery of renal denervation, significantly improves responder rate to the therapy, and can be also used to assess whether an efficient ablation is delivered for renal sympathetic denervation. the unique position of symap in renal denervation field is protected by a portfolio of ips (pending), and the proprietary technology platform of symap has been granted with usa crt2012 best innovation award.
suzhou symap medical ltd is located at suzhou biobay as an innovative medical device company. the company is founded by an excellent team with outstanding reputation and exceptional experience in cardiovascular medical device field in both china and us. symap is dedicated to developing a proprietary catheter-based renal mapping and ablation system for renal denervation therapy to treat hypertension and other diseases, such as heart failure, arrhythmia, renal failure, diabetics and sleep apnea, etc. our novel renal mapping and ablation technology optimizes the delivery of renal denervation, significantly improves responder rate to the therapy, and can be also used to assess whether an efficient ablation is delivered for renal sympathetic denervation. the unique position of symap in renal denervation field is protected by a portfolio of ips (pending), and the proprietary technology platform of symap has been granted with usa crt2012 best innovation award.
联系方式
- 公司地址：上班地址：苏州市工业园区星湖街218号生物纳米园B8栋2楼