Medical Quality Systems Specialist II

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.

Ensures adherence to established quality standards, ISO 13485, EU Medical Device Regulations, Health Canada and FDA regulations.

* Writes and maintains applicable procedures, work instructions and forms. * Monitors the Quality Management System for effectiveness, opportunities for improvement and risk. * Performs CAPA and NCMR process management. * Ensures implementation of regulatory requirements into Quality Management System processes. * Documents compliant investigations and maintains document controls. * Tracks and reports quality related metrics. * Supports QA review and approval of design and validation documents. * Maintains FDA annual registration and device listing. * Develops key metrics, processes, internal control evaluation, document control and management reviews in compliance with quality standards and regulations. * Evaluates deficiencies in current processes and recommends changes to remedy problems. * Facilities internal training on quality assurance requirements, processes and procedures. * Performs internal and external audits and risk assessments as needed. * May be assigned additional duties and/or special projects.

* Requires a Bachelor's degree in a related field and 2-5 years' experience in a quality assurance or regulatory affairs role in a FDA regulated environment. * Working knowledge of FDA Quality System Regulations 21 CFR Part 820 and Part 11, ISO 13485:2012, Health Canadaand European Medical Device Directives. * Certified Lead or ASQ Auditor a plus. * Strong computer, written and interpersonal skills. * Attention to detail. * May have to work overtime and may be assigned to other shifts based on company needs.