Description
The Medical Device Manufacturing Quality and Regulatory Engineer supports plant and project teams with quality, regulatory, manufacturing, and process-control issues. The role leads or participates in Kaizen and continuous-improvement projects, investigates defects, applies FMEA, risk mitigation, validations, DOE, Six Sigma, and Lean methods, coordinates machine and process capability studies, supports new-product and process evaluations, and ensures compliance with OSHA, EPA, FDA, ISO, and other applicable regulations. A BA/BS degree in science, engineering, or a related discipline is required; medical-device manufacturing experience and 1–2 years of relevant experience are preferred, with internships, co-op experience, and relevant engineering projects also considered.
