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 will leverage cutting-edge AI testing capabilities and support 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. Focus: AI-powered software quality assurance and validation
Domain: Life sciences document management and version control
Environment: AI-assisted software development
Objective: Deliver high-quality, compliant software that meets GxP and regulatory requirements Your future duties and responsibilities
AI-Driven Testing & User Acceptance Testing * 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. Validation & Regulatory Compliance * 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. Collaboration & Continuous Improvement * 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. Required qualifications to be successful in this role
* 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. Domain Expertise * 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. Professional 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. Bachelor's degree in computer science, Engineering, or a related field, or equivalent professional experience. Other Information:
CGI is required by law in some jurisdictions to include a reasonable estimate of the compensation range for this role. The determination of this range includes various factors not limited to skill set, level, experience, relevant training, and licensure and certifications. To support the ability to reward for merit based performance, CGI typically does not hire individuals at or near the top of the range for their role. Compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range for this role in the U.S. is $77,800.00 $103,800.00. CGI's benefits are offered to eligible professionals on their first day of employment to include:
. 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 #LI-MP2 Together, as owners, let’s turn meaningful insights into action. Life at CGI is rooted in ownership, teamwork, respect and belonging. Here, you’ll reach your full potential because… You are invited to be an owner from day 1 as we work together to bring our Dream to life. That’s why we call ourselves CGI Partners rather than employees. We benefit from our collective success and actively shape our company’s strategy and direction. Your work creates value. You’ll develop innovative solutions and build relationships with teammates and clients while accessing global capabilities to scale your ideas, embrace new opportunities, and benefit from expansive industry and technology expertise. You’ll shape your career by joining a company built to grow and last. You’ll be supported by leaders who care about your health and well-being and provide you with opportunities to deepen your skills and broaden your horizons. Come join our team—one of the largest IT and business consulting services firms in the world. Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, pregnancy, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status or responsibilities, reproductive health decisions, political affiliation, genetic information, height, weight, or any other legally protected status or characteristics to the extent required by applicable federal, state, and/or local laws where we do business. CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at [email protected] . You will need to reference the Position ID of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a Position ID will not be returned. We make it easy to translate military experience and skills! Click here to be directed to our site that is dedicated to veterans and transitioning service members. All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held. Dependent upon role and/or federal government security clearance requirements, and in accordance with applicable laws, some background investigations may include a credit check. CGI will consider for employment qualified applicants with arrests and conviction records in accordance with all local regulations and ordinances. CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.
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