Manufacturing and Quality Engineering Manager
Core
Lead design, development, and modification of surgical products while managing daily technical support and manufacturing facility modernization.
Role type
Manufacturing and Quality Engineering Manager
Builds
Surgical medical devices and related manufacturing processes
Domain
Medical Devices / 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, project management, ISO 13485 compliance, 21 CFR 820 compliance, continuous improvement, statistical process control, CAPA management, budget planning, strategic planning
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 and change orders; manage personnel for efficiency and performance; control manufacturing projects for cost reduction; ensure product quality meets customer requirements; implement and monitor Quality Management Systems; develop shop floor inspection systems; work with customers to resolve quality issues; initiate corrective and preventive actions; perform statistical analysis of processes and products; drive continuous improvement programs to reduce waste; ensure compliance with ISO and FDA regulations; assist with budget and strategic planning.
Seniority
Senior, hands-on IC with management responsibilities
