Precision QC Inspector – Medical Devices

Angel Aligner; Oak Creek (WI); Presencial; USD 45.000 - 65.000; Jornada completa

Descripción de la vacante

Angel Aligner is seeking a QC Inspector in Oak Creek, WI, to perform in-process, incoming, and final inspections of medical-device components, ensuring compliance with FDA 21 CFR Part 820 and ISO 13485. You will document results for audit readiness and support root-cause investigations.

The role requires 1–3 years of QC inspection experience in regulated manufacturing, ability to read engineering drawings, and proficiency with inspection tools. Cleanroom/controlled-environment work is common.

Formación

• Read and interpret engineering drawings and specifications.
• Proficiency with basic and advanced inspection tools.
• 1–3 years of QC inspection experience in medical devices or regulated manufacturing.

Responsabilidades

• Perform incoming, in-process, and final inspections using visual, dimensional, and functional tests.
• Conduct functional and mechanical testing of components and finished devices.
• Document inspection results with traceability and accuracy.
• Verify product against engineering drawings and work instructions.
• Conduct first article inspections (FAI) and complete related documentation.
• Inspect labeling, packaging, and UDI information for accuracy and compliance.
• Document inspection results in DHRs and electronic quality systems.
• Identify, document, and segregate nonconforming material; initiate NCRs.

Conocimientos

Engineering drawings

Inspection tools

Documentation

Attention to detail

Independent work

Communication skills

GMP/GDP awareness

Educación

High school diploma or equivalent

Technical certificate

Associate degree

Herramientas

Calipers

Micrometers

Height gauges

Optical comparators

Descripción del empleo

Angel Aligner is seeking a QC Inspector in Oak Creek, WI, to perform in-process, incoming, and final inspections of medical-device components, ensuring compliance with FDA 21 CFR Part 820 and ISO 13485. You will document results for audit readiness and support root-cause investigations.

The role requires 1–3 years of QC inspection experience in regulated manufacturing, ability to read engineering drawings, and proficiency with inspection tools. Cleanroom/controlled-environment work is common.