北京招聘

Job Description/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 Evaluation & 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;
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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);

   北京天智航医疗科技股份有限公司，成立于2005年，国内最早专业从事手术机器人研发的高科技企业。2010年，公司取得了我国首个医疗机器人产品注册许可证，成为全球第五家获得医疗机器人注册许可证的公司，填补了国内空白，在骨科机器人技术领域处于国际领先水平。公司核心产品“骨科手术机器人”入选科技部国家重点新产品计划并荣获2014年北京市科学技术一等奖和2015年国家科学技术进步奖二等奖。2016年6月，公司研发的新一代天玑骨科手术机器人系统受邀参加国家“十二五”科技创新成就展，作为生物技术与人口健康领域重大标志性科技成果向包括***主席在内的党和***进行演示汇报。2016年11月，天玑骨科手术机器人系统取得国家食品药品监督管理颁发的医疗器械产品注册证并正式上市，成为国际***获准上市的能够开展四肢、骨盆骨折以及脊柱全节段手术的骨科机器人系统。2015年11月，公司在新三板挂牌（股票代码：834360），成为国内首家在新三板挂牌的医疗机器人企业。