Specialist, Regulatory Affairs /Quality Systems Associate – Canon USA – Irvine, CA


Company Overview:
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. With approximately $31 billion in global revenue, its parent company, Canon Inc. (NYSE: CAJ), ranks third overall in U.S. patents granted in 2014† and is one of Fortune Magazine’s World’s Most Admired Companies in 2015. In 2014, Canon U.S.A. has received the PCMag.com Readers’ Choice Award for Service and Reliability in the digital camera and printer categories for the 11th consecutive year. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company’s RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com. † Based on weekly patent counts issued by United States Patent and Trademark Office. All referenced product names, and other marks, are trademarks of their respective owners.

Canon is proud to be an equal opportunity employer. Minority/Female/Individuals with Disabilities/Protected Veterans. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristic protected by law. To read more about employment discrimination protections under federal law, please visit this site: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

Position Overview:
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.

Responsibilities:
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.

Qualifications:
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.

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Canon U.S.A., Inc., headquartered in Melville, New York, is a leading provider of consumer, business-to-business, and industrial digital…



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