Software Quality Assurance Consultant

Katalyst Healthcares & Life Sciences • Kearny, NJ

201d

About The Position

Join a leading biomedical software development project and provide Quality Assurance oversight throughout the Software Development Life Cycle (SDLC), ensuring compliance with regulatory standards (FDA/GMP). You'll act as a QA subject matter expert on cross-functional teams.

Requirements

• Bachelor's degree (required).
• 10–15 years of QA experience, ideally in a medical device or FDA-regulated environment.
• In-depth knowledge of SDLC, risk management, and configuration management.
• Excellent written and verbal communication skills.
• Able to collaborate effectively in cross-disciplinary teams in a fast-paced setting.

Responsibilities

• Provide QA oversight and regulatory compliance across software development and validation phases.
• Review project documentation: requirements, designs, test plans/cases, and summary reports.
• Identify and resolve software defects and develop CAPAs.
• Act as internal QA advisor across teams.
• Lead/participate in cross-functional process improvement efforts.
• Monitor evolving biomedical regulatory standards.
• Approve internal procedures to ensure regulatory compliance.

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree