Job Description

Overview

Join a leading medical device manufacturer focused on precision and patient safety. We’re seeking a dependable Quality Inspector to perform hands-on inspections of mechanical and electromechanical components used in radiographic imaging equipment. This is a long-term, full-time opportunity with steady hours, supportive leadership, and growth potential.

What You’ll Do

• Inspect incoming parts, in-process assemblies, and finished devices

• Use precision tools including calipers, micrometers, and multimeters

• Read and interpret blueprints, schematics, and GD&T symbols

• Document inspection results and complete nonconformance reports (NCRs)

• Support CAPA and root cause investigations with the quality team

• Verify calibration and maintain inspection equipment

• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485 standards

• Maintain a clean, organized inspection area and follow safety procedures

What You’ll Need

• High school diploma or GED (technical certification preferred)

• 2+ years of experience in quality inspection or manufacturing

• Proficiency with inspection tools and measurement techniques

• Familiarity with FDA, ISO 13485, and GMP regulations

• Ability to lift 25 lbs and perform manual/visual inspections

• Must pass a basic measuring test using calipers and micrometers

Preferred Qualifications

• Experience in medical device or precision assembly environments

• IPC-A-610 certification or training in root cause analysis (5 Whys, Fishbone)

• Knowledge of ERP/QMS systems (SAP, IQMS, or similar)

You should be proficient in:

• GD&T
• Quality Inspection Experience
• ISO 13485
• Measurement System Analysis (MSA)
• Statistical process control (SPC)
• 5 Why (Root Cause Analysis Method)
• Fishbone Diagram (Ishikawa Diagram)
• FDA Regulations
• Standard Operating Procedures (SOPs)
• Kaizen
• Quality Control Experience
• Tolerance Analysis
• Mechanical Testing
• Blueprint Reading

Machines & technologies you'll use:

• Coordinate Measuring Machine (CMM) (Zeiss, Mitutoyo, Hexagon, Faro)
• Measurement Gauges
• Calipers and Micrometers