Quality Assurance Entry Level - Medical Device (Only on W2)

$58,240 - $62,400/Yr

Kyyba - Green Oaks, IL

Full-time - Entry Level

Green Oaks, IL

Professional, Scientific, and Technical Services

About the position

We are seeking a meticulous QA Specialist - Entry Level to join our team, responsible for ensuring the quality of products and services meets established standards in the medical device industry. This role involves participating in design control, risk management, design verification and validation, documentation review, and ensuring compliance with quality systems.

Responsibilities

• 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 FMEA's.
• Understand and apply basic Design Verification/Validation methods and principles, participating in the development and modification of Protocols, Data Summaries, and Records.
• Review documentation for accuracy, clarity, consistency, completeness, and compliance for projects of varying complexity.
• Maintain awareness of industry standards and ensure compliance with site-level policies and procedures, reporting non-compliance issues to management.
• Participate on project teams and technical review boards, coordinating quality decisions between different quality and engineering groups.
• Apply quality principles, analyze quality records, prepare reports, and recommend improvements.
• 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.
• Knowledge of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, and 21 CFR Part 11 preferred.
• 1 year of manufacturing experience preferred.

Benefits

• Contract position with a pay range of $28.00 - $30.00 per hour.
• Expected hours: 40 per week, with a schedule of 8-hour shifts from Monday to Friday.