Description
The Quality Engineering Manager leads product quality, regulatory compliance, validation, nonconformance, CAPA, customer complaint, and failure-mode investigations in a regulated medical device environment. The role reviews and approves technical and validation data, guides Quality Engineers and other staff, supports environmental and supplier quality activities, and promotes continuous improvement. It requires a bachelor's degree in engineering, technology, or a related science, 4–5 years of relevant regulated-industry experience, and expertise in ISO 13485, quality systems, validation, root-cause analysis, statistical tools, and technical documentation.
