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.

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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.