QC Technician

Hydrogen Group; Minneapolis (MN); On-site; USD 40,000 - 60,000; Full time

Job summary

A medical device company is seeking a Quality Control Technician to perform inspections and testing to ensure compliance with established quality standards and regulations. The role requires 1-3 years of relevant experience and a high school diploma, with a preference for an associate degree in science or engineering. Responsibilities include inspecting incoming materials and final products, maintaining records, and communicating findings with cross-functional teams. Detail orientation and knowledge of GMP are critical for success in this position.

Qualifications

• 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 and specifications.

Responsibilities

• Perform inspections of medical device components and products.
• Conduct visual and functional inspections according to specifications.
• Maintain inspection equipment and logs.

Skills

Attention to detail

Documentation accuracy

Inspection techniques

Understanding of GMP

Education

High school diploma or GED

Associate degree in science or engineering

Tools

Calipers

Micrometers

Gauges

Microsoft Office

Job description

Reports To: QC Supervisor / Quality Manager

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

Job Summary

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.

Key Responsibilities

• 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

Required Qualifications

• 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

Preferred Qualifications

• 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

Physical Requirements

• 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