Description
The Quality Engineer will oversee quality activities across new product development, sustaining engineering changes, risk management, and Design History File documentation. The role ensures compliance with design control, quality management system, regulatory, and applicable standards; reviews design planning, reviews, validation and verification, design transfer, engineering change and engineering change request approvals, and change documentation; and maintains traceability among requirements, design inputs, outputs, risk controls, and validation activities. The position requires a bachelor's degree in engineering or a related technical or medical discipline, at least five years of medical-device quality engineering experience, experience with ISO 13485 and ISO 14971, and fluency in English and Microsoft Office.
