上海朗迈医疗器械科技有限公司专注于骨科微创，特别是脊柱微创和运动医学领域的产品设计与开发，研发方向覆盖骨质疏松性椎体压缩骨折（OVCF）治疗，单纯椎间盘病变的脊柱内镜治疗(Spine Endoscopy)和关节镜下微创治疗（Arthroscopy）等领域。公司致力于提供骨科微创的整套解决方案，是一家集研发、制造、销售和服务于一体的创新型企业。目前已上市的产品包括椎体压缩性骨折（OVCF）治疗的完整解决方案：雅升®（Ascend®) 经皮球囊后凸成形术和椎体成形术系统, 雅升®（Ascend®) 可控弯经皮球囊后凸成形术和可控弯椎体成形术系统, Eurofix®（欧固®）脊柱骨水泥，脊柱内镜下微迈™（Wave™）双极射频消融电极，关节镜下奥科™（Orchestra™) 关节低温等离子射频消融电极和微创外科微泰针™(Versatile™）一次性针形高频电极。其中Ascend®（雅升®) 可控弯球囊后凸成形术系统（SPKP）和可控弯经皮椎体成形术系统（SPVP），Wave™（微迈™）脊柱内镜下射频消融电极均为创新的骨科医疗器械产品。Shanghai Legend… Show more 上海朗迈医疗器械科技有限公司专注于骨科微创，特别是脊柱微创和运动医学领域的产品设计与开发，研发方向覆盖骨质疏松性椎体压缩骨折（OVCF）治疗，单纯椎间盘病变的脊柱内镜治疗(Spine Endoscopy)和关节镜下微创治疗（Arthroscopy）等领域。公司致力于提供骨科微创的整套解决方案，是一家集研发、制造、销售和服务于一体的创新型企业。目前已上市的产品包括椎体压缩性骨折（OVCF）治疗的完整解决方案：雅升®（Ascend®) 经皮球囊后凸成形术和椎体成形术系统, 雅升®（Ascend®) 可控弯经皮球囊后凸成形术和可控弯椎体成形术系统, Eurofix®（欧固®）脊柱骨水泥，脊柱内镜下微迈™（Wave™）双极射频消融电极，关节镜下奥科™（Orchestra™) 关节低温等离子射频消融电极和微创外科微泰针™(Versatile™）一次性针形高频电极。其中Ascend®（雅升®) 可控弯球囊后凸成形术系统（SPKP）和可控弯经皮椎体成形术系统（SPVP），Wave™（微迈™）脊柱内镜下射频消融电极均为创新的骨科医疗器械产品。Shanghai Legend Medical & Technology Co., Ltd (SLMT) specializes in developing and marketing minimal invasive orthopedics products, covering treatment of OVCF, Spine endoscopy and Arthroscopy. Current portfolio includes Ascend®（雅升®) Kyphoplasty & Vertebroplasty System, Eurofix®（欧固®） VTP Spine Bone Cement, Orchestra™（奥科™) Arthroplasty Ablation System, Wave™（微迈™）Spine Endoscopic RF probe and Versatile™ disposable electrode. Ascend®（雅升®) Steerable Kyphoplasty（SPKP), Steerable Vertebroplasty System （SPVP) and Wave™（微迈™）Spine Endoscopic RF probes are one of the most innovative technology/products in China orthopedics market. Show less

Working in Suzhou Lischka Medtech co.,Ltd as QA manager. In charge of: Establish and implement the medical device quality management system to ensure site procedures meet ISO14385，CFR820 and Domestic laws and regulations requirements, including internal audit, external audit, management review and corrective action follow up and so on.; Response for product quality control including supplier quality management, process quality control, final product release, collect process quality data and… Show more Working in Suzhou Lischka Medtech co.,Ltd as QA manager. In charge of: Establish and implement the medical device quality management system to ensure site procedures meet ISO14385，CFR820 and Domestic laws and regulations requirements, including internal audit, external audit, management review and corrective action follow up and so on.; Response for product quality control including supplier quality management, process quality control, final product release, collect process quality data and quality trend analysis etc. Responsible for CE, CFDA and FDA registration, Prepare and conduct of Regulatory Compliance Plan for new products, including clinical study, quality system Audit, type testing and registration. Prepare and conduct of yearly Registration Plan for Product license re-new and change. Follow-up and interpret regulations and policy, especially CFDA. Build and maintain effective working relationships with Regulatory Agency and Testing Center. Show less

Mar.2013~Mar.2015 Working in Kunshan Hwa Jiuh Precision Metal Co.,Ltd as QA vice manager, In charge of Integrate the quality procedures; Periodical maintenance and continual improvement the ISO9001 and TS16949 Quality Management System; Lead and coordinate internal and external audit and follow up corrective/preventive action; establish criterion of instruments and calibrate instrument; be responsible for creating, reviewing and updating control plan and FMEA; Involve in new project or… Show more Mar.2013~Mar.2015 Working in Kunshan Hwa Jiuh Precision Metal Co.,Ltd as QA vice manager, In charge of Integrate the quality procedures; Periodical maintenance and continual improvement the ISO9001 and TS16949 Quality Management System; Lead and coordinate internal and external audit and follow up corrective/preventive action; establish criterion of instruments and calibrate instrument; be responsible for creating, reviewing and updating control plan and FMEA; Involve in new project or product development, prepare and document APQP, PPAP etc Customer service, including presentation of quality system , plant tour accompanying, 8D submission; harmonize and communicate with relate department to solve all kinds of process abnormity; Preside inner meeting of department; control quality of production and so on . Skilled in operate of ERP system and MRP system. Show less