Medical Device Quality Assurance Engineer

Medical Device Quality Assurance Engineer

  • Medical Device Quality Assurance Engineer

    Location US-MA-Cambridge

    Company Canon U.S.A., Inc.

    Requisition ID
    Medical Device
    Position Type


Be a part of the Quality team at our Healthcare Optics Research Laboratory and drive Quality for the development of unique biomedical devices in collaboration with world’s leading medical institutions. We are seeking an experienced Medical Device Quality Assurance Engineer (Engineer, Quality Assurance) who can lead design assurance, risk management and supplier management activities and drive compliance.


- Performs, participates in and maintains quality evaluations to ensure that products are properly designed, meets users’ needs and are documented in accordance with regulatory requirements
- Collaborates with engineering laboratory and production functions to ensure quality standards are in place
- Participates in the design and implementation of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products design and test equipment
- Develops and analyzes inspection and testing processes, mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess control and manage risks of quality of the product and coordinates the determination of the responsibility for products or materials that do not meet required standards and specifications
- May undertake root cause analysis of incidents requiring corrective action
- Ensures that design changes are compliant with requirements
- Performs Quality Assurance processes related to document control and change management, nonconforming product, equipment controls, CAPAs, and supplier management
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
- Utilizes quality tools to help drive continuous improvement to ensure products and Quality System processes are designed and documented in compliance with FDA’s QSR requirements and for participating in risk assessments for ensuring product safety
- May perform Design Validation and Verification testing, including software testing


- Engineers are developing professionals, acquiring the skills and experience necessary to become fully proficient in the field of product or process development
- Requires a bachelor's degree in an engineering discipline plus 3 - 5 years of related experience, or a Master's degree in the field

Company Overview

About our Company - 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 $36 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2018† and is one of Fortune Magazine's World's Most Admired Companies in 2019. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. 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 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.

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