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Quality Engineer

2 weeks ago

Boston, United States Beacon Engineering Resources Full time

Quality Engineer The Quality Engineer will ensure that medical device products meet regulatory and company standards throughout design, development, and manufacturing. Responsibilities include supporting design controls, risk management, and verification/validation activities, as well as reviewing documentation, managing nonconformances, and leading corrective and preventive actions. The role works closely with cross-functional teams to maintain compliance with FDA, ISO 13485, and other regulations, while driving process improvements to ensure product quality, safety, and reliability. Qualifications: Bachelor’s degree in engineering or related field Experience in quality engineering within medical devices or regulated industries Knowledge of FDA 21 CFR Part 820, ISO 13485, and risk management practices Strong problem-solving, documentation, and communication skills