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)

●公司概況:
北京天智航醫療科技股份有限公司成立于2010年10月，位于中關村東升科技園（地鐵8號線永泰莊站附近），是在北京天智航技術有限公司基礎上進行股份制改造設立，專業從事醫療機器人以及相關智能醫療裝備開發、生產和銷售，同時為醫療機構提供智能醫療的綜合解決方案的高新技術企業。公司取得了國內首個醫療機器人注冊許可證，是全球第五家擁有醫療機器人注冊許可證公司，擁有醫療器械生產企業許可證、醫療器械經營企業許可證及建筑企業資質，是中關村醫療器械產業技術創新聯盟理事長單位和醫療機器人北京市工程實驗室依托單位。

●發展歷程:
2000年，
臨床專家和工程專家思想碰撞，開始了骨科機器人的科學探索；
2001年，
首次獲得科技部863計劃項目支持；
2004年，
完成國內首例骨科機器人手術；
2005年，
北京天智航技術有限公司成立，致力于骨科機器人研制和產業化；
2010年，
骨科機器人榮獲2010年中關村十大企業技術創新成果獎；
骨科機器人獲得SFDA注冊許可，填補國內空白；
天智航公司獲得北京市政府重大科技成果產業化股權投資；
2011年，
醫療機器人北京市工程實驗室掛牌；
公司董事長張送根博士入選“高聚工程”，獲“中關村高端領軍人才”認定；
2012年，
作為理事長單位發起設立中關村醫療器械產業技術創新聯盟；
2013年，
全國多家醫院骨科機器人微創手術中心成功運營；
2014年，
骨科機器人獲“中關村首臺（套）重大技術裝備示范項目”認定；
骨科機器人入選科技部“2014年度國家重點新產品計劃”；
《基于影像導航和機器人技術的智能骨科手術體系研究及臨床應用項目》榮獲北京市科學技術一等獎；
公司董事長張送根博士入選“2014年國家創新人才推進計劃”。

公司地址：北京市海淀區西小口路66號東升科技園C區1號樓二層
公司官網：www.tinavi.com