Quality System
Able to comprehend Quality System requirements plan, prepare and execute systems to ensure compliance with QSR, ISO, and EN requirements.
Review and improve existing quality procedure workflows and identify areas of improvement for efficiency.
Conduct quality audits at own and vendor ****s to assess compliance to applicable standards and regulations prepare and execute **** plans to improve overall compliance.
Independently author concise quality investigation reports with appropriate corrective **** and preventive ****s (CAPA)
Review new and modified product design specifications including product performance specifications, test methods, acceptance criteria, and release to manufacturing.
Understanding and coaching others on Quality Systems and procedures.

Product Development
Contribute as a team member on development projects carrying out assigned quality assurance responsibilities in a timely, diligent, safe, and professional manner.
Contribute to development and maintenance of Design History Files in a manner consistent with regulatory requirements.
Provide quality-related inputs to projects on product reliability, in meeting quality deliverables.
Guide the development of quality plans, execute inspection & testing activities and work further with Manufacturing on the transfer of quality requirements.
Provide statistical inputs on product testing and control of quality characteristics.
Support R&D in device product/process development and production activities.
Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools

数字影像诊断行业知名加拿大公司，在同行业中属于Leading Company。