ROLE AND RESPONSIBILITIES
Summary
Quality Director (QD) for the Wuxi facility. The QD will oversee all QA activities relating to manufacturing, installation and service in the APAC region. The ideal candidate will be proactive, detail oriented with a customer focused approach to all compliance activities.
Reporting to CEO of the Quality Management and Regulatory Office.

Major Tasks include:
-Deploy the New-RT Quality Management System at the Wuxi facility
-Ensure all quality activities performed at Wuxi, are conducted in compliance to both YY/T0287-2017 (ISO 13485) and FDA QSR Quality Management Systems
-Foster a strong compliance culture, that includes employee education, as well as maintaining a roadmap for the continuous improvement of the Quality Management System
-Ensure build instructions, workmanship standards and specifications are available at all stages of manufacturing including receiving inspections, assembly, final test, packaging/shipping and installation/commissioning
-Ensure all quality records are complete, accurate and readily available
-Manages supplier uation and monitoring for all APAC based suppliers, this includes conducting supplier audits and managing the supplier corrective program
-Support the internal audit program as needed
-Host all third-party audit visits and manage all follow up activities
-Manage the process for identifying, analyzing, correcting and documenting product non-conformities and rework activities
-Manage the Corrective and Preventive process at the Wuxi facility
-Report on Wuxi quality activities and performance against defined ives at management review meetings
-Maintain calibration records for all tools used in the manufacturing, installation and service of the device
-Hire, manage and develop talent to ensure the continuing success of the function

QUALIFICATIONS AND EDUCATION REQUIREMENTS
Bachelors Degree (or equivalent experience) and 10-15 years of related experience, or Masters Degree with 6-10 years of related experience.

Preferred Skills
-Proven record of success in related manufacturing environment for complex electro-mechanical systems.
-Medical device or regulated industry experience
-Ability to motivate and influence others
-Lead Auditor ISO 13485
- in Lean Manufacturing/6 Sigma principles a strong advantage
-Excellent English with strong interpersonal skills

新瑞阳光粒子医疗装备（无锡）有限公司是总部位于美国加州硅谷的NewRT Medical Systems, Inc.在中国的全资子公司。公司由一批来自全球顶尖放疗设备厂商Varian, IBA, 美国著名大学和国家实验室的高级专家和高级技术管理人员创建，并获得美元基金的巨额投资和无锡当地政府的大力支持，专注于新一代影像引导放疗装置的开发、生产和销售，立志打造世界水平的国产化先进放疗装置。

公司诚邀有志于挑战癌症，造福患者的精英加盟，共同打造中国创造的顶尖放疗装置，为癌症患者带来新的阳光！