Senior Quality Control (QC) Engineer – AI-Driven Testing & Validation

CGI is seeking a forward-thinking Senior QC Engineer to lead software quality assurance, validation, and User Acceptance Testing (UAT) for our next-generation life sciences document version control platform. This role leverages cutting-edge AI testing capabilities and supports an AI-assisted software development lifecycle while ensuring compliance with GxP and other regulatory standards. This position can be based near any CGI US office in a hybrid work model.

Responsibilities

• Leverage AI-powered testing tools to improve software quality and testing efficiency.
• Design, generate, and maintain automated test cases using AI-assisted testing technologies.
• Validate AI-generated code and ensure it meets functional, performance, and compliance requirements.
• Plan, coordinate, and execute User Acceptance Testing (UAT) with business stakeholders.
• Analyze AI-identified defects, anomalies, and risk areas, ensuring timely resolution.
• Ensure software development and testing activities comply with GxP regulations and Computer Software Validation (CSV) requirements.
• Develop and maintain validation documentation, including validation plans, protocols, test scripts, and summary reports.
• Support audit readiness by maintaining complete traceability of electronic records and testing evidence.
• Ensure solutions comply with FDA 21 CFR Part 11 and other applicable regulatory standards.
• Partner closely with AI-assisted software developers, product owners, and business stakeholders to define quality requirements.
• Collaborate with Quality Assurance and Regulatory teams to ensure validation activities align with compliance expectations.
• Drive continuous improvement of quality engineering processes, automation frameworks, and AI-enabled testing practices.

Requirements

• 5+ years of experience in software Quality Assurance, Quality Control, or Software Validation.
• Experience using AI-enabled software testing or test automation platforms.
• Hands-on experience with test automation frameworks such as Selenium or Playwright.
• Ability to read, understand, and troubleshoot code written in Python or JavaScript.
• Experience in the life sciences, pharmaceutical, biotechnology, or healthcare industries.
• Strong understanding of Computer Software Validation (CSV) methodologies and GxP regulations.
• Experience testing document management, document control, or regulated content management systems is preferred.
• Familiarity with FDA 21 CFR Part 11 and electronic records/electronic signatures compliance.
• Bachelor's degree in computer science, Engineering, or a related field, or equivalent professional experience.

Skills

• Strong analytical and problem-solving abilities with exceptional attention to detail.
• Understanding of AI governance, validation, and the importance of mitigating bias in AI-assisted solutions.
• Excellent communication and collaboration skills with cross-functional technical and regulatory teams.
• Ability to thrive in a fast-paced Agile development environment supporting rapid AI-enabled innovation.

Benefits

• Competitive compensation
• Comprehensive insurance options
• Matching contributions through the 401(k) plan and the share purchase plan
• Paid time off for vacation, holidays, and sick time
• Paid parental leave
• Learning opportunities and tuition assistance
• Wellness and well-being programs

Pay

A reasonable estimate of the current range for this role in the U.S. is $77,800.00 - $103,800.00.