Qualitex NE LLC

Qualitex NE LLC is a precision contract manufacturing specialist serving the medical device, automotive, appliance, and agricultural sectors. The company operates two primary business units: Qualitex Medical and Qualitex Gage. Qualitex Medical is an ISO 9001, ISO 13485, and FDA-registered medical device manufacturer offering rapid prototyping, production machining, and full assembly capabilities for orthopedic implants, surgical instruments, and custom medical components. The company has manufactured over 35,000 external fixation rings for foot and ankle surgeries and 6,800+ surgical instruments for OEM partners ranging from Fortune 500 companies to startups. Qualitex Gage provides custom-designed gage and check fixtures for dimensional verification and quality control across industries. The company maintains an ISO 17025-accredited metrology laboratory equipped with multiple CMMs and optical comparators, supporting inspection processes and dimensional analysis. Core capabilities include CNC machining, wire EDM, CMM programming, production machining, and SPC systems implementation. Quality certifications include ISO 9001 and ISO 13485 for medical manufacturing, with demonstrated expertise in geometric dimensioning and tolerancing, dimensional layout services, and automated gage systems with PLC integration.