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 worlds leading medical institutions. We are seeking an experienced Senior Quality Assurance Engineer (Sr Engineer, Quality Assurance) who can lead design assurance, risk management and supplier management activities and drive compliance.
- As a quality representative on the projects core team or extended team, takes responsibility of ensuring that all design control activities including design inputs, design and development planning, design reviews, design verification and validation, test method validation, and design transfer efforts are compliant and meet FDAs expectations. Review and approve design control and product documentation
- Ensure product safety by driving risk management activities including authoring risk management plans, interfacing with Medical Affairs, and facilitating and mentoring engineers on system risk assessments and FMEAs
- Provide guidance on the selection of statistical analyses and sample size for design verification and validation and other qualification and acceptance testing
- Support the successful transfer of products to manufacturing by ensuring the adequacy of process validation, design transfer plans, quality plans and supplier documentation
- Participate in creating and implementing quality system processes
- May participate in supplier management efforts for evaluating and approving key suppliers and developing quality agreements with consultants and contract manufacturers
- May plan and execute internal audits against applicable quality system standards, regulations and internal requirements
- B.S. or higher degree in engineering, or similar
- 5 years minimum experience with a minimum of 2 years of Medical Device experience and a minimum of 5 years of Quality experience or design control experience, 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
- 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
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 2017 and is one of Fortune Magazine's World's Most Admired Companies in 2018. 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 www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact [email protected].
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