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