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Quality Assurance Engineer
Quality Assurance Engineer
KestraKestra is seeking a Quality Engineer to ensure new and modified medical devices meet customer expectations, regulatory requirements (FDA QSR, ISO 13485, EU MDR), and company policies. This role actively participates in product development, transfer activities, and risk management throughout the product lifecycle. The ideal candidate will have a Bachelor's degree in Engineering or a related field with 2+ years of experience in Quality or Engineering, along with significant experience in risk management and relevant regulatory standards. You will champion continuous improvement, act as the QA representative on design projects, and provide statistical support for product development.
