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(yī)療科技股份有限公司成立于2010年10月，位于中關(guān)村東升科技園（地鐵8號(hào)線永泰莊站附近），是在北京天智航技術(shù)有限公司基礎(chǔ)上進(jìn)行股份制改造設(shè)立，專業(yè)從事醫(yī)療機(jī)器人以及相關(guān)智能醫(yī)療裝備開發(fā)、生產(chǎn)和銷售，同時(shí)為醫(yī)療機(jī)構(gòu)提供智能醫(yī)療的綜合解決方案的高新技術(shù)企業(yè)。公司取得了國(guó)內(nèi)首個(gè)醫(yī)療機(jī)器人注冊(cè)許可證，是全球第五家擁有醫(yī)療機(jī)器人注冊(cè)許可證公司，擁有醫(yī)療器械生產(chǎn)企業(yè)許可證、醫(yī)療器械經(jīng)營(yíng)企業(yè)許可證及建筑企業(yè)資質(zhì)，是中關(guān)村醫(yī)療器械產(chǎn)業(yè)技術(shù)創(chuàng)新聯(lián)盟理事長(zhǎng)單位和醫(yī)療機(jī)器人北京市工程實(shí)驗(yàn)室依托單位。

●發(fā)展歷程:
2000年，
臨床專家和工程專家思想碰撞，開始了骨科機(jī)器人的科學(xué)探索；
2001年，
首次獲得科技部863計(jì)劃項(xiàng)目支持；
2004年，
完成國(guó)內(nèi)首例骨科機(jī)器人手術(shù)；
2005年，
北京天智航技術(shù)有限公司成立，致力于骨科機(jī)器人研制和產(chǎn)業(yè)化；
2010年，
骨科機(jī)器人榮獲2010年中關(guān)村十大企業(yè)技術(shù)創(chuàng)新成果獎(jiǎng)；
骨科機(jī)器人獲得SFDA注冊(cè)許可，填補(bǔ)國(guó)內(nèi)空白；
天智航公司獲得北京市政府重大科技成果產(chǎn)業(yè)化股權(quán)投資；
2011年，
醫(yī)療機(jī)器人北京市工程實(shí)驗(yàn)室掛牌；
公司董事長(zhǎng)張送根博士入選“高聚工程”，獲“中關(guān)村高端領(lǐng)軍人才”認(rèn)定；
2012年，
作為理事長(zhǎng)單位發(fā)起設(shè)立中關(guān)村醫(yī)療器械產(chǎn)業(yè)技術(shù)創(chuàng)新聯(lián)盟；
2013年，
全國(guó)多家醫(yī)院骨科機(jī)器人微創(chuàng)手術(shù)中心成功運(yùn)營(yíng)；
2014年，
骨科機(jī)器人獲“中關(guān)村首臺(tái)（套）重大技術(shù)裝備示范項(xiàng)目”認(rèn)定；
骨科機(jī)器人入選科技部“2014年度國(guó)家重點(diǎn)新產(chǎn)品計(jì)劃”；
《基于影像導(dǎo)航和機(jī)器人技術(shù)的智能骨科手術(shù)體系研究及臨床應(yīng)用項(xiàng)目》榮獲北京市科學(xué)技術(shù)一等獎(jiǎng)；
公司董事長(zhǎng)張送根博士入選“2014年國(guó)家創(chuàng)新人才推進(jìn)計(jì)劃”。

公司地址：北京市海淀區(qū)西小口路66號(hào)東升科技園C區(qū)1號(hào)樓二層
公司官網(wǎng)：www.tinavi.com