Quality Control

We are hiring on behalf of our client for a detail-oriented Quality Control Inspector to support incoming, in-process, and final inspections within a medical device manufacturing environment. This role is responsible for ensuring products meet quality standards and regulatory requirements in compliance with ISO 13485 and FDA 21 CFR 820 guidelines.

Responsibilities

• Perform incoming, in-process, and final inspections following work instructions and inspection plans
• Conduct first article inspections and AQL sampling inspections
• Inspect components and finished products using tools such as:
  • Calipers
  • Digital height gauges
  • Optical comparators
  • Vision systems
  • Durometers
  • Visual inspection equipment
• Properly label and disposition inspected materials
• Record inspection and test data in accordance with Good Documentation Practices (GDP)
• Support nonconformance investigations and rework inspections
• Interpret manufacturing drawings, diagrams, and specifications
• Assist with quality documentation updates and audit support activities
• Collaborate with production and quality teams to maintain compliance with company procedures and regulatory standards

Qualifications

• 4+ years of quality inspection experience within a medical device or regulated manufacturing environment
• Working knowledge of ISO 13485 and FDA 21 CFR 820 requirements
• Experience with AQL sampling and inspection processes
• Proficiency using inspection and measurement equipment
• Ability to read and interpret technical drawings and specifications
• ERP system experience preferred
• Strong attention to detail and documentation accuracy
• Solid communication and organizational skills
• Basic computer proficiency required