QC Technician

Reports To:

QC Supervisor / Quality Manager

Shift: 7:00am - 3:30pm, M-F

The Quality Control Technician is responsible for performing inspections, tests, and documentation activities to ensure medical device components and finished products meet established quality standards, regulatory requirements, and internal specifications. This role supports incoming materials, in-process manufacturing, and final product release in a regulated environment.

• Perform incoming, in-process, and final inspections of medical device components and finished products
• Conduct visual, dimensional, and functional inspections according to approved procedures and specifications
• Use measurement tools such as calipers, micrometers, gauges, rulers, and microscopes
• Accurately complete inspection records, batch records, and Device History Records (DHRs)
• Review labels, packaging, and documentation for accuracy and compliance
• Identify, document, and escalate nonconforming materials and inspection failures
• Maintain inspection equipment, logs, and calibration status
• Follow GMP, GDP, ISO 13485, and FDA quality system requirements
• Assist with investigations, CAPA activities, and continuous improvement initiatives as needed
• Communicate inspection results with Manufacturing, Engineering, and Quality teams

• High school diploma or GED required; associate degree in science or engineering preferred
• 1-3 years of quality control, inspection, or regulated manufacturing experience
• Basic understanding of GMP and regulated quality systems
• Ability to read and interpret engineering drawings, specifications, and SOPs
• Proficiency with Microsoft Office; experience with E-QMS or ERP systems is a plus
• Strong attention to detail and documentation accuracy

• Experience working in a medical device, biotech, or pharmaceutical environment
• Familiarity with FDA 21 CFR Part 820 and ISO 13485
• Experience with nonconformance reporting and root cause investigations
• Experience in cleanroom or controlled manufacturing environments

• Ability to stand or sit for extended periods
• Manual dexterity to handle small components
• Ability to lift up to 25-40 lbs as required
• Manufacturing and/or cleanroom environment
• May require gowning and adherence to cleanroom protocols