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