Software Quality Assurance Engineer

The Fountain Group is currently seeking a Software Quality Assurance Engineer for a prominent client of ours. This position is located in Lake Forest, IL 60045. Details for the position are as follows:

Pay Rate : $40 Hourly on W2 - ONSITE

Title : Software Quality Assurance Engineer
Duration : 6 Months assignment, possibility for extension or conversion based on performance and budget.
Location: 675 North Field Drive - Lake Forest, IL 60045

What to look for:

• Software Quality / Compliance person ensuring the software is developed, tested, documented, risk-assessed, and released in accordance with Abbott's quality system and regulatory requirements.
• Software development medical-device quality regulatory compliance risk management
• Medical device / regulated healthcare Software Quality
• Software validation/testing within a regulated SDLC
• Risk management
• Medical-device quality/regulatory knowledge - FDA / 21 CFR 820 / ISO 13485 / IEC 62304 / ISO 14971

Required Skills

• Software Quality Assurance and Testing
• Regulatory Compliance in Healthcare/Medical Device Environment
• Quality Systems and Compliance Management
• Risk Management and Documentation
• Cross-Functional Team Collaboration
• Independent Problem Solving and Ownership
• Product Safety and Effectiveness Evaluation

Preferred Qualifications

• Knowledge of Software Development Lifecycle (SDLC)
• Experience with Cloud-Based Software Applications
• Understanding of Cybersecurity Standards and Requirements
• Experience supporting regulated healthcare software development projects

Experience

• 5 years of Quality Assurance or Quality-related experience within a regulated environment.
• Experience supporting healthcare, medical device, pharmaceutical, or similarly regulated industries preferred.

If you are interested in hearing more about the position, please respond to this posting with your resume attached.

Please forward this posting to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.

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