Manufacturing Quality Engineer - Intellectt : Job Details

Role: Manufacturing & Quality Engineer

Location: Cincinnati, Ohio

Position Overview

We are seeking an experienced Manufacturing & Quality Engineer to support process improvements, new product transfers, and equipment validation within a medical device manufacturing environment. The ideal candidate will bring strong technical expertise in quality systems, machining, and lean methodologies while ensuring compliance with FDA/ISO regulations.

Key Responsibilities

• Drive process improvements using Statistical Analysis, Lean, Six Sigma, and GMP principles.
• Support new product introductions and design change transfers to the production floor.
• Implement machining and safety enhancements to reduce scrap and improve performance.
• Develop and maintain technical protocols, process documentation, visual instructions, and training materials.
• Lead equipment specification, procurement, and validation activities.
• Ensure compliance with FDA/ISO standards, design control requirements, and reprocessing guidelines.

Qualifications

• Bachelor's degree in Engineering with 4+ years of medical device manufacturing experience.
• Strong knowledge of quality systems, GD&T, machining processes, and orthopedic products.
• Hands-on experience with engineering change orders, structured troubleshooting, test lab development, and Lean methodologies.
• Preferred background in extrusion, polymers, micro tubing, and process validation.