Senior Quality Inspector — Precision Medical Devices

Express Employment Professionals - Cincinnati East

Henderson (NC)

On-site

USD 55,000 - 75,000

Full time

3 days ago
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Job summary

Express Employment Professionals - Cincinnati East is seeking a Senior Quality Inspector Advanced Manufacturing to conduct incoming, FA I, in-process, and final inspections of precision machined medical device components in full compliance with ISO 13485:2016 and FDA 21 CFR 820. This in-person role reports to the Head of Quality and requires strong GD&T proficiency and meticulous measurement discipline.

The position operates 7:00 AM to 3:30 PM with potential overtime.

Qualifications

  • Technical diploma or equivalent in Engineering, Manufacturing, or related field.
  • 2+ years of inspection experience in machining, precision manufacturing, 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, etc.).
  • Ability to perform dimensional inspection using CMM (Hexagon preferred).
  • Familiarity with ISO 13485:2016 and FDA 21 CFR 820 (QMSR) preferred.

Responsibilities

  • Perform incoming, first article (FAI), in-process, and final inspection per procedures and drawings.
  • 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.
  • Verify calibration status and maintain inspection equipment; support calibration activities.
  • Maintain GDP-compliant records; ensure traceability and data integrity.
  • Support FAI, MSA, and process validation activities; ensure product identification and traceability.
  • Maintain 5S in inspection area and comply with safety, GMP, and regulatory requirements.

Skills

GD&T
Measurement
CMM use
Documentation GDP
ERP/MES
MS Office

Education

Technical diploma in Engineering/Manufacturing

Tools

CMM (Hexagon)
Calipers
Micrometers
Height gauges
Gages

Job description

Express Employment Professionals - Cincinnati East is seeking a Senior Quality Inspector Advanced Manufacturing to conduct incoming, FA I, in-process, and final inspections of precision machined medical device components in full compliance with ISO 13485:2016 and FDA 21 CFR 820. This in-person role reports to the Head of Quality and requires strong GD&T proficiency and meticulous measurement discipline.

The position operates 7:00 AM to 3:30 PM with potential overtime.

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