QA Specialist

$56,160 - $62,400/Yr

Intellectt - Green Oaks, IL

Full-time - Entry Level

Green Oaks, IL

Professional, Scientific, and Technical Services

About the position

The QA Specialist role at Abbott Diagnostics Division focuses on ensuring quality standards for components, materials, and services. The position involves analyzing quality standards, participating in design control activities, and ensuring compliance with industry regulations. The specialist will work on risk management, design verification and validation, and documentation review, contributing to the overall quality assurance processes within the organization.

Responsibilities

• Analyze quality standards for components, materials, or services.
• Apply measures, sampling methods, testing methodology, and other procedures to ensure quality standards are met.
• Participate in the development and review of design input, risk management, design verification, design validation, and design output/transfer related design change activity.
• Understand and apply basic Risk Management principles, including the development and modification of Risk Management Files and FMEAs.
• Participate in the development, modification, and design review of Protocols, Data Summaries, and Records for Design Verification/Validation.
• Review documentation for accuracy, clarity, consistency, completeness, and compliance for projects of varying complexity.
• Ensure compliance with site-level policies and procedures by reporting non-compliance issues to management.
• Participate on project teams and technical review boards, coordinating quality decisions between different quality and engineering groups.
• Conduct inspection, verification, and validation of components or materials used in development processes.
• Document quality issues and performance measures for management review.

Requirements

• Bachelor's Degree required.
• 1 year of manufacturing experience preferred.
• Knowledge of FDA regulations, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11 preferred.

Benefits

• Contract position with competitive hourly pay of $27.00 - $30.00 per hour.