Medical Device QA Inspector, GMP & ISO 13485

Stellar IT Solutions LLC; Madison (WI); On-site; USD 55,000 - 85,000; Full time

Job summary

Stellar IT Solutions LLC in Madison, WI seeks a Quality Assurance professional to ensure materials, processes and device manufacturing meet GMP and ISO13485 standards within the quality system.

You will inspect raw materials, perform in-process checks, review final documentation and packaging, support documentation control, and assist investigations of nonconformances to uphold regulatory compliance across manufacturing, engineering and quality teams.

Qualifications

• High School diploma or equivalent.
• Experience in a regulated work environment preferred.
• Knowledge of FDA QSR and ISO13485 pertaining to medical device manufacturing.

Responsibilities

• Inspecting raw materials to meet production requirements.
• Conducts in-process inspection of manufacturing product and processes.
• Reviews final documentation and shipment packaging for medical devices, subassemblies, and kits.
• Assists in Madison Manufacturing documentation control room.
• Completes documentation of activities performed, prepares and attaches material quality status labeling.
• Supports investigations of nonconformance and preventive actions within QA.

Skills

Attention to detail

Written communication

Team collaboration

Computer systems

Education

HS diploma

Tools

Electronic documentation systems

Job description

Stellar IT Solutions LLC in Madison, WI seeks a Quality Assurance professional to ensure materials, processes and device manufacturing meet GMP and ISO13485 standards within the quality system.

You will inspect raw materials, perform in-process checks, review final documentation and packaging, support documentation control, and assist investigations of nonconformances to uphold regulatory compliance across manufacturing, engineering and quality teams.