Quality Technician II - Critical Medical Components/Devices

Job Description

Job Description

Quality Technician – Critical Medical Devices

About the Role:

As a Quality Technician, you’ll be responsible for performing detailed inspections and functional tests on critical components and/or finished medical devices. This role is focused on inspection and testing—requiring precision, consistency, and a solid understanding of medical device standards. You’ll work closely with Quality Engineers and Production to proactively identify gaps to compliance, verify documentation, and support continuous improvement. This position will play a very active role on the floor in support of daily operations and manufacturing execution. This role will support our growth on our 2nd shift and will work Monday through Friday, 4:30pm-3am. (4-10 hour shifts)

Key Responsibilities:

• Perform dimensional and visual inspections on critical medical device components or assemblies using various measurement tools like calipers, micrometers, vision inspection equipment, gauges, etc.
• Conduct functional tests and verify conformance to detailed specifications and tolerances
• Interpret engineering drawings, specifications, and work instructions
• Record and maintain accurate inspection data, including lot history and traceability records
• Support lot release, material review, and root cause analysis for nonconforming parts
• Participate in audits and provide complete, well-organized inspection documentation
• Assist in implementing corrective actions and reinforcing compliance with ISO 13485 and FDA regulations
• Ensuring adherence to GDP (Good Documentation Practices) and GMP (Good Manufacturing Practices) requirements
• Nonconformance, CAPA, and Material Review Board Support

What You Bring:

• Minimum 3–5 years of quality technical experience in the medical device industry required.
• Proven experience inspecting critical or high-precision components and/or devices.
• Familiarity with ISO 13485, and Good Documentation Practices (GDP)
• Proficiency with inspection equipment and interpreting engineering drawings and GD&T
• Experience using Excel, electronic QMS platforms (e.g., Minitab, ETQ, Master Control), and document control systems
• Excellent attention to detail, organization, and communication skills

Preferred Qualifications:

• CQI or CQT certification
• Experience with cleanroom manufacturing in a medical device setting.
• Working knowledge of SPC and data analysis tools such as Minitab
• Familiarity with Failure Investigation techniques.

Why This Role Matters:
This isn’t just another inspection job—you’ll be directly responsible for ensuring the integrity of a component essential to patient outcomes. Your work will help ensure that only the highest-quality components and devices are released for assembly and use in the field.