Medical Device Quality Inspector | GMP & ISO 13485

Energy Jobline ZR; Madison (WI); On-site; USD 50,000 - 70,000; Full time

Job summary

Select Source International (SSI) in Madison, WI is seeking a Quality Inspector to ensure materials, processes and finished devices meet GMP and ISO13485 standards.

The role conducts material and in-process inspections, maintains documentation, and supports investigations of nonconformances to uphold product quality and regulatory compliance. The position emphasizes accurate labeling, controlled storage, and collaboration with QA in a regulated medical device environment.

Qualifications

• High School diploma or equivalent.
• One year’s experience in a regulated work environment.
• Knowledge of FDA Quality System Regulations and ISO13485 pertaining to medical device manufacturing.

Responsibilities

• Inspections of raw materials to meet production requirements.
• In-process inspection of manufacturing product and processes.
• Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits.
• Assists in the Madison Manufacturing documentation control room.
• Completes documentation of activities performed, prepares and attaches material quality status labeling.
• Ensures storage and handling of product and labeling in a controlled and secure manner.
• Supports Quality through occasional investigations of nonconformance, assists with preventive actions.
• Performs quality reviews for quarantine releases on nonreportable, non-complaint, RMF-3 internal to an RSC.

Skills

Quality inspection

GMP

Regulatory compliance

Documentation

Education

High School diploma

1 year regulated work experience

Job description

Select Source International (SSI) in Madison, WI is seeking a Quality Inspector to ensure materials, processes and finished devices meet GMP and ISO13485 standards.

The role conducts material and in-process inspections, maintains documentation, and supports investigations of nonconformances to uphold product quality and regulatory compliance. The position emphasizes accurate labeling, controlled storage, and collaboration with QA in a regulated medical device environment.