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Sr. Medical Device Quality Specialist
Canon
Boca Raton, FL, United States
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Company Overview
Virtual Imaging, Inc. is a wholly-owned subsidiary of Canon U.S.A., Inc. Canon U.S.A's extensive product line and digital solutions enable businesses and consumers worldwide to capture, store and distribute information. Virtual Imaging specializes in the sale, service, and maintenance of diagnostic imaging equipment for optimal patient care. Collaborating with large complex hospitals, government organizations, medical facilities, and security agencies, Virtual Imaging offers advanced digital radiography technology, such as diagnostic equipment, digital flat panel technology, and imaging solutions to improve overall workflow and efficiency. To learn more about the seamless synergy of Canon’s wide range of digital radiography and fluoroscopy solutions with Virtual Imaging’s leading RadPRO product portfolio and how they can meet the diverse needs of healthcare providers.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.,
† 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.
Position Overview
Lead efforts to maintain the quality management system to be compliant to ISO13485:2016, via MDSAP. Leads the Internal audit program to ensure that the required internal audits are conducted. Maintain compliance to FDA 21-CFR 820 & SOR 98-282- Health Canada, and all applicable regulations for 21 CFR 1020.30.
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Responsibilities
Additional Responsibilities include document control, complaint management, supplier management, supplier audits, training, process improvements, design control and manage projects. Promote culture of quality and mentor cross functional teams. Lead a daily Quality Standup Meeting to address quality issues with process, product and customers.
Qualifications
• ASQ Certification as lead auditor or equivalent training
• Expertise in Microsoft Word, Excel
• Bachelor's degree in related field or minimum of 5 years industry experience, plus knowledge of regulations in the field of medical devices, specifically for Radiographic systems
• Experience with Medical Device Single Audit Program
• Able to work independently with little supervision