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

新瑞陽光粒子醫療裝備（無錫）有限公司是總部位于美國加州硅谷的NewRT Medical Systems, Inc.在中國的全資子公司。公司由一批來自全球頂尖放療設備廠商Varian, IBA, 美國著名大學和國家實驗室的高級專家和高級技術管理人員創建，并獲得美元基金的巨額投資和無錫當地政府的大力支持，專注于新一代影像引導放療裝置的開發、生產和銷售，立志打造世界水平的國產化先進放療裝置。

公司誠邀有志于挑戰癌癥，造福患者的精英加盟，共同打造中國創造的頂尖放療裝置，為癌癥患者帶來新的陽光！