Job Deion/Requirements:

•Develop the end to end R & D quality system in alignment with the health authority and industrial requirements
•Ensuring project team compliance with the Quality Management Systems, government regulations & international standards requirements
•Supporting product development efforts by preparing quality plans, reviewing design plans, overseeing qualification, risk management & validation processes, and ensuring appropriate control plans are provided for design transfer
•Ensure appropriate Design Inputs and Design Outputs in evidence for project and adequate documentation and traceability are provided in the Design History File
•Leader to ensure robust verification, validation, and transfer of product designs are established
•Ensure appropriate training is in evidence for Design Teams on Design Control and Quality Systems
•Expert in verification and validation procedures and approaches for robust qualification of product and process designs
•Provide quality approvals of plans, procedures, and reports for verification and validation activities and ensure robust justification of all protocol deviations and non-conformances
•Provide guidance on compliance requirements for ISO, European MDD (Medical Devices Directive), FDA (Food & Drug Administration) /QSR (Quality Systems Regulations), &CFDA regulations
•Partner with regulatory experts for initial regulatory review in support of design change requests

•Support risk assessment activities: FMEA (Failure Mode uation & Analysis) & FTA (Fault Tree Analysis)
•Lead the supplier special process validation and process verification to insure the process and product meet company requirements
•Ensure robust investigations and timely closure of manufacturing and field non-conformances
•Develop system and provide oversight of design team activities to identify critical-to-quality design features and ensure adequate control plans for product and process designs to demonstrate product is ready to market & manufacture on an ongoing basis

Qualifications
•Bachelor or above in engineering or scientific discipline
•Job Experience: 8 years+
•Bilingual: English/Mandarin required
•Solid Knowledge/experience of Product design quality control in the Medical Devices industry.
•Extensive experience with ISO 13485/ 14971 and QSR Design Control standards
•GD&T knowledge
•Self-managed—work with minimal supervision
•Comprehensive problem-solving skills.
•Knowledge of Regulatory compliance: GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), MDD (Medical Devices Directive), 510K (Pre-market Notification)

●公司概况:
北京天智航医疗科技股份有限公司成立于2010年10月，位于中关村东升科技园（地铁8号线永泰庄站附近），是在北京天智航技术有限公司基础上进行股份制改造设立，专业从事医疗机器人以及相关智能医疗装备开发、生产和销售，同时为医疗机构提供智能医疗的综合解决方案的高新技术企业。公司取得了国内首个医疗机器人注册许可证，是全球第五家拥有医疗机器人注册许可证公司，拥有医疗器械生产企业许可证、医疗器械经营企业许可证及建筑企业资质，是中关村医疗器械产业技术创新联盟理事长单位和医疗机器人北京市工程实验室依托单位。

●发展历程:
2000年，
临床专家和工程专家思想碰撞，开始了骨科机器人的科学探索；
2001年，
首次获得科技部863计划项目支持；
2004年，
完成国内首例骨科机器人手术；
2005年，
北京天智航技术有限公司成立，致力于骨科机器人研制和产业化；
2010年，
骨科机器人荣获2010年中关村十大企业技术创新成果奖；
骨科机器人获得SFDA注册许可，填补国内空白；
天智航公司获得北京市政府重大科技成果产业化股权投资；
2011年，
医疗机器人北京市工程实验室挂牌；
公司董事长张送根博士入选“高聚工程”，获“中关村高端领军人才”认定；
2012年，
作为理事长单位发起设立中关村医疗器械产业技术创新联盟；
2013年，
全国多家医院骨科机器人微创手术中心成功运营；
2014年，
骨科机器人获“中关村首台（套）重大技术装备示范项目”认定；
骨科机器人入选科技部“2014年度国家重点新产品计划”；
《基于影像导航和机器人技术的智能骨科手术体系研究及临床应用项目》荣获北京市科学技术一等奖；
公司董事长张送根博士入选“2014年国家创新人才推进计划”。

公司地址：北京市海淀区西小口路66号东升科技园C区1号楼二层
公司官网：www.tinavi.com