Role : QA Specialist I(Medical Devices)

Location : North Chicago, IL

Duration : 5 Months

The Quality Assurance Specialist ensures compliance with quality standards for components, materials, and services. Key responsibilities include risk management, design control, documentation review, and adherence to quality system regulations.

Key Responsibilities:

• Design/Change Control: Participate in design inputs, risk management, design verification/validation, and design change activities.
• Risk Management: Apply risk management principles and assist with risk file and FMEA development.
• Verification/Validation: Contribute to design verification/validation protocols and data review.
• Documentation: Ensure accuracy, clarity, and compliance of quality documentation.
• Quality System Compliance: Maintain compliance with industry standards, reporting non-compliance promptly.
• Quality Engineering: Collaborate with project teams to deliver safe and effective products.
• Inspect, verify, and validate components/materials, and recommend quality improvements.

Qualifications:

• Required: Bachelor’s degree.
• Preferred: Knowledge of FDA regulations, QSR, ISO guidelines, and 21 CFR Part 11.