Quality Control Inspector I

Quality Control Inspector responsible for inspecting spinal and orthopedic implants and instrumentation at various production stages. Role includes verifying product and raw material quality against standards, managing nonconforming material, maintaining GMP-compliant records, and supporting regulatory compliance in a medical device manufacturing environment.

Responsibilities

• Perform inspections of products and raw materials at multiple production stages to meet quality standards
• Maintain and archive quality records, Device History Records, and documentation per GMP requirements
• Identify, segregate, and manage nonconforming material; coordinate dispositions with cross-functional teams
• Manage component and assembly releases using QAD system and ERP transactions
• Support external audits and ensure compliance with FDA, QSR, and ISO 13485 requirements

Requirements

• Quality Inspector certification or advanced studies in relevant technical discipline
• Minimum three years directly related quality inspection experience
• Medical device industry experience, preferably Class II or III environments
• Knowledge of FDA regulations, QSR, and ISO 13485 standards
• Ability to read technical documents, job travelers, sketches, and procedural materials
• Proficiency with measurement instruments and microscopic inspection of small components
• Proficiency in Microsoft Office products