Specialist, Reg Aff/QS Associate

Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean (excluding Mexico) markets.

We have an exciting opportunity in our Irvine office to assist Department management in the Healthcare Solutions Division with quality programs and system activities in the medical device arena. The ideal candidate will ensure the Company adheres to FDA quality and regulatory guidelines.

Assist with product complaint and MDR management system, quality metrics, reporting, perform regulatory inspections and QSR audits, issue audit reports, special projects. * Assist with international registrations projects coordinating with government entities. * Interface with sales administration on vendor compliance issues. * Assist in maintenance of quality systems to ensure compliance with ISO, QSR and Corporate requirements. * Assist with CAPA and inspection activities.

* Bachelor’s degree in a science discipline preferred, or equivalent experience in a medical device / pharmaceutical industry. * 2 years of RA/QS experience in a FDA regulated environment is required, including complaint management. * Familiar with FDA, QSR and ISO standards. * Excellent written and verbal communication skills. * Intermediate computer skills.