Senior Quality Inspector – Medical Device, Precision Machining

Express Employment International (US); Henderson (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Express Employment International (US) in Henderson, NC seeks a Senior Quality Inspector for advanced manufacturing. You will perform incoming, first article (FAI), in-process, and final inspections on precision machined and assembled medical device components to ensure compliance with ISO 13485:2016 and FDA 21 CFR 820.

You will make product-acceptance decisions and support nonconformance control. The role requires meticulous data entry, GDP adherence, and collaboration with production and

Qualifications

• Minimum of a technical diploma or equivalent in Engineering, Manufacturing or related field.
• 2+ years of inspection experience in machining or regulated manufacturing (medical device preferred).
• Ability to read and interpret engineering drawings, including basic GD&T.
• Proficient in using precision measuring instruments (calipers, micrometers, height gauges, bore gauges, thread gauges, plug gauges, ring gauges, dial indicators, surface roughness testers).
• Ability to perform dimensional inspection using CMM (Hexagon preferred).
• Familiarity with ISO 13485:2016 and FDA 21 CFR 820 (QMSR) preferred.
• Strong attention to detail and GDP compliance.
• Ability to work independently and in a team in a fast-paced environment.

Responsibilities

• Inspect incoming, FAI, in-process, and final components to drawings and specifications.
• Verify dimensional, visual, and functional conformance; ensure only conforming product is released.
• Support disposition decisions and communicate results to production and engineering.
• Identify, document, and segregate nonconforming materials; initiate NCRs and support MRB/CAPA.
• Verify calibration status of inspection equipment and maintain measurement tools.
• Record inspection results following GDP; ensure traceability of records and batch release docs.
• Support FAI, MSA, and process validation activities; maintain traceability.
• Maintain clean, compliant inspection area per 5S and regulatory requirements.
• Perform other duties to support manufacturing and quality.

Skills

GD&T reading

Precision measurement

CMM measurement

ISO 13485 & FDA 21 CFR 820 knowledge

GDP

MSA/FAI exposure

ERP/MES experience

Reading drawings

Education

Technical diploma or equivalent in Engineering, Manufacturing, or related field

Tools

CMM (Hexagon)

Micrometers/Calipers/Height gauges

Inspection tools & gauges

ERP/MES systems

Job description

Express Employment International (US) in Henderson, NC seeks a Senior Quality Inspector for advanced manufacturing. You will perform incoming, first article (FAI), in-process, and final inspections on precision machined and assembled medical device components to ensure compliance with ISO 13485:2016 and FDA 21 CFR 820.

You will make product-acceptance decisions and support nonconformance control. The role requires meticulous data entry, GDP adherence, and collaboration with production and