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


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 2015† and is one of Fortune Magazine’s World’s Most Admired Companies in 2016.

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 .† 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.We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.

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 complaints and MDR management system, quality metrics, reporting, perform product inspections and QSR audits, good documentation practices, issue audit reports and 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.Responsible for document control to include writing procedures. Excellent understanding of documentation (good documentation practices) required in a medical device/pharma environmentEnsure that all Design History projects comply with regulatory, developer, and company requirements for HS products.Assist in training staff on pertinent regulatory and pertinent issues, as assigned by department senior staff. Topics include inspections, document compliance, etc.Conduct and/or participate in specialized audits, i.e.: documentation, integration, CAPA, procedure manuals, labeling, etc.Coordinate department annual records retention projects to ensure compliance with regulatory requirementsConduct product inspections, i.e.: receiving and integration with department administrative staffParticipate in company Quality Management Review meetingsAssist department and senior management and participates in regulatory investigations.

Participation includes, but is not limited to: answering questions on documentation, taking inspection notes with Inspection Coordinator, identification of relevant inspection documents, etc.Assist with Complaint integrations into Complaint databaseInitiate and/or assist with trending of documentation metrics for company Management Review and additional meeting forums Bachelor’s degree in a science discipline preferred. Experience with digital radiography and/or opthalmic products preferred.Min. 1 year of RA/QS experience in a FDA regulated environment is required, including complaint management and documentation.Familiar with FDA, QSR and ISO standards.Excellent written and verbal communication skills.Intermediate MS office computer skillsExperience interfacing with regulatory agencies, i.e., FDA is highly desirableAbility to provide routine trending on documentation projects, as requiredIf you are not reviewing this job posting on our Careers’ site https://www.usa.canon.com/internet/portal/us/home/about/careers, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at https://www.usa.canon.com/internet/portal/us/home/about/careers.

“medical device” MDR CAPA



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