Quality Inspector, Medical Devices (ISO 13485)

Ki Mobility; Stevens Point (WI); On-site; USD 52,000 - 78,000; Full time

Job summary

Ki Mobility is seeking a Quality Inspector in Stevens Point, WI to coordinate, perform, and document quality inspections ensuring products are defect-free and compliant with ISO 13485, FDA 21 CFR Part 820, and related regulations. The role emphasizes data recording, nonconformance handling, and collaboration with engineering and production teams.

The successful candidate will work in a regulated manufacturing environment, utilize precision measuring tools, and support continuous improvement

Qualifications

• Read and interpret engineering drawings and SOPs.
• Experience with measurement techniques and inspection records.
• Familiar with quality systems and regulatory expectations.

Responsibilities

• Read and interpret engineering drawings, specifications and SOPs.
• Select inspection samples and perform inspections per procedures.
• Record inspection results and maintain quality reports.
• Identify nonconformances and coordinate corrective actions.
• Support CAPA activities and internal/external audits.
• Collaborate with engineering and production to resolve quality issues.

Skills

GD&T

Shop math

Measurement

Written comms

MS Office

Independent & team

Adaptable

Data analysis

Education

ASQ CQIA/CQI/CQT preferred

Tools

Calipers

Micrometers

Height gauges

Pin gauges

Job description

Ki Mobility is seeking a Quality Inspector in Stevens Point, WI to coordinate, perform, and document quality inspections ensuring products are defect-free and compliant with ISO 13485, FDA 21 CFR Part 820, and related regulations. The role emphasizes data recording, nonconformance handling, and collaboration with engineering and production teams.

The successful candidate will work in a regulated manufacturing environment, utilize precision measuring tools, and support continuous improvement