Canon USA & Affiliates Regulatory Affairs / Quality Systems, Sr. Specialist in Irvine, California

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 markets. With approximately $29 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2016† 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 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.

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

#LI-NF1 #CUSA

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.

  • Oversee product complaint processing and MDR program including trending, reports and presentations. Administers Corrective Action and Preventative Action (CAPA)

  • Manage all activities of Document Control process.

  • Perform internal and external auditing of systems, departments, products, as required. Issue audit reports and ensure timely audit closures.

  • Coordinate international registrations projects with Department Management, including procuring documents and legalizations from regulatory, County, State and specific country legal bodies. Interface with Sales Administration on vendor compliance issues.

  • Support the maintenance of HealthCare Solutions quality systems to ensure compliance with QSR, ISO, and Corporate requirements.

  • Perform incoming, in-process, and integration inspection activities. Issue documentation, as applicable.

  • Support regulatory inspections, as applicable.

  • Author and revise Department SOP’s, Department Procedures, policies and forms.

  • Bachelor’s Degree required, preferably in science or healthcare discipline.

  • Minimum five years in Regulatory Affairs and/or Quality Systems (medical device experience highly preferred)

  • Demonstrated familiarity with FDA QSR, and specific ISO standards.

  • Excellent written and verbal communication skills

  • Strong computer skills, i.e. Word, Excel, Power Point, etc.

  • Results oriented, self-starter and dependable.

  • Ability to lift up to 20 lbs

    If 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

ID: 7564

External Company URL: http://www.usa.canon.com

Address: 15955 Alton Parkway

Company Overview (Text Only): 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 markets. With approximately $29 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2016† 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 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.

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

#LI-NF1 #CUSA

Responsibilities (Text Only): - Oversee product complaint processing and MDR program including trending, reports and presentations. Administers Corrective Action and Preventative Action (CAPA) - Manage all activities of Document Control process. - Perform internal and external auditing of systems, departments, products, as required. Issue audit reports and ensure timely audit closures. - Coordinate international registrations projects with Department Management, including procuring documents and legalizations from regulatory, County, State and specific country legal bodies. Interface with Sales Administration on vendor compliance issues. - Support the maintenance of HealthCare Solutions quality systems to ensure compliance with QSR, ISO, and Corporate requirements. - Perform incoming, in-process, and integration inspection activities. Issue documentation, as applicable. - Support regulatory inspections, as applicable. - Author and revise Department SOP’s, Department Procedures, policies and forms.

Qualifications (Text Only): - Bachelor’s Degree required, preferably in science or healthcare discipline. - Minimum five years in Regulatory Affairs and/or Quality Systems (medical device experience highly preferred) - Demonstrated familiarity with FDA QSR, and specific ISO standards. - Excellent written and verbal communication skills - Strong computer skills, i.e. Word, Excel, Power Point, etc. - Results oriented, self-starter and dependable. - Ability to lift up to 20 lbs If 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

Canon is proud to be an equal opportunity/affirmative action employer. Minority/Female/Individuals with Disabilities/Veteran. We value the diversity of our workforce and knowledge of our people. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identification, national origin, disability, genetic information or protected veteran status, or any other characteristic protected by law. To view the "EEO is the Law" poster, click here, and to view the supplement, click here. To read our Pay Transparency Statement, click here.

Canon is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require a reasonable accommodation in order to complete an employment application, or during the application process, please contact our Talent Acquisition Department at CanonCareers@cusa.canon.com, which will route you to Canon’s Talent Acquisition Support Team.