Software Quality Assurance Engineer - III

generis Tek • Lake Forest, IL

1d • Onsite

About The Position

The Software Quality Assurance Engineer III will be responsible for ensuring regulatory compliance and quality assurance for healthcare software products. This role focuses on supporting quality system compliance activities, software validation efforts, risk management processes, and regulatory requirements within a highly regulated healthcare environment. The ideal candidate will work independently, partner with cross-functional teams across multiple geographic locations, and help ensure that software solutions are compliant, practical, innovative, and aligned with organizational objectives. This individual may lead quality initiatives and represent the QA function on cross-functional project teams while supporting the ongoing effectiveness of Quality Systems, key processes, and regulatory compliance programs.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a closely related discipline; equivalent combination of education and experience may be considered.
• Minimum 5 years of experience in a Quality Assurance or Quality-related role.
• Experience performing software testing in a regulated industry environment.
• Strong understanding of healthcare industry standards, regulations, and regulatory agencies.
• Demonstrated experience with risk management methodologies and product compliance activities.
• Ability to work independently and take ownership of assigned responsibilities.
• Proven ability to collaborate effectively with cross-functional teams across multiple locations.
• 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

Nice To Haves

• 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

Responsibilities

• Ensure regulatory compliance for healthcare software products and related quality processes.
• Support and maintain Quality System effectiveness by identifying, addressing, and documenting non-compliance issues.
• Perform software quality assurance and testing activities within a regulated environment.
• Create, review, and maintain risk management documentation to evaluate and mitigate product risks.
• Collaborate with cross-functional teams to ensure product safety, effectiveness, and compliance throughout the development lifecycle.
• Participate in quality and compliance initiatives that support organizational and regulatory objectives.
• Provide quality oversight and guidance for software development and validation activities.
• Contribute to project execution and represent QA on cross-functional teams as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior