Typically five or more years of experience in quality inspection, quality engineering support, medical device manufacturing, or a related regulated manufacturing environment.
Demonstrated experience independently leading nonconformance investigations and root cause analysis activities.
Advanced knowledge of nonconformance processes, inspection methods, and quality system requirements in a regulated manufacturing setting.
Strong ability to interpret engineering drawings, specifications, assembly procedures, workmanship standards, and acceptance criteria.
Advanced proficiency with measuring and inspection equipment used in production and quality control environments.
Demonstrated ability to lead root cause investigations and support the implementation of effective corrective actions.
Strong technical writing and documentation skills, including the ability to produce clear, concise, and complete quality records.
Advanced experience using ERP, manufacturing, document control, and electronic quality systems, including Epicor or similar platforms.