Manufacturing & Quality Engineering Manager
Core
Leading manufacturing processes, new product releases, and quality systems for surgical cutting tools and accessories.
Role type
Manufacturing & Quality Engineering Manager
Builds
Surgical cutting tools, components, and accessories
Domain
Medical device manufacturing / Surgical instruments
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
manufacturing process management, new product release implementation, ISO 13485 and 21 CFR 820 compliance, continuous improvement, statistical process analysis, CAPA management, project management, team leadership
Preferred skills
advanced degree in engineering or business, experience with FDA regulations
Technologies
ISO 13485, 21 CFR 820, CAPA systems, statistical analysis tools
Responsibilities
Lead product development, change orders, and production support; manage personnel to meet efficiency objectives; control manufacturing projects and drive cost reductions; ensure product quality meets customer requirements; oversee the Quality Management System and implement continuous improvement activities; perform statistical analysis of processes and products; ensure compliance with ISO and FDA regulations; lead routine meetings to resolve issues and drive improvement.
Seniority
Senior, hands-on IC with management responsibilities