Sr. Quality Assurance Engineer

US-MA-Cambridge
Job ID
7227
Experience (Years)
5

Company Overview

The Canon Healthcare Optics Research Laboratory is a division of Canon U.S.A., Inc.
 
Canon Healthcare Optics Research Lab (HORL) is a young organization that is gaining momentum. We’re partnering with world class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. 
 
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.

Position Overview

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 Senior Quality Engineer who can lead design assurance, risk management and supplier management activities and drive compliance.

Responsibilities

• Work collaboratively with R&D engineers providing guidance and participation in design inputs, design and development planning, design reviews, design verification and validation, and design transfer efforts. Review and approve design control and product documentation.
• Facilitate risk management activities including risk management plans, system risk assessments, and FMEAs.
• Lead supplier management efforts, including supplier approval, supplier audits and developing quality agreements.
• Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other testing.
• Support successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation.
• Document, implement and manage quality system processes.
• Plan and execute internal audits against applicable quality system standards, regulations and internal requirements.

Qualifications

• Education: BS or higher degree in engineering, or similar.
• Experience: 5 years minimum quality engineering experience in Medical Devices, including experience in leading design control and risk management activities. Experience in supplier management is a plus.
• In-depth understanding of design control and risk management.
• In-depth, working knowledge of the requirements of FDA QSRs, ISO 13485 and ISO 14971.
• Certification as an internal lead auditor for QSRs and/or ISO 13485 is a plus.
• Skills: Proficient in Microsoft Office. Experience in Minitab, JMP or similar statistical package.
• Must be a team player and possess strong oral and written communication skills.
• Applicants are encouraged to provide writing samples that demonstrate their capabilities in creating design control documentation and writing quality management procedures.

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