Senior Software QA Engineer

Are you passionate about ensuring the safety and reliability of cutting-edge software as medical devices? At CergenX, we’re transforming healthcare with innovative solutions, and we’re looking for a Senior Software QA Engineer to join our dynamic team. If you’re a meticulous professional with expertise in medical device software testing and regulatory compliance, we want to hear from you!

Key responsibilities

🔍 Design, develop, and execute test cases to verify software functionality, safety, and performance against regulatory standards.

📝 Create and maintain comprehensive test plans, protocols, and reports to meet regulatory and internal requirements.

🐞 Identify, log, and track defects, working closely with QA/RA, AI, and software development teams for prompt resolution.

⚠️ Participate in risk assessment activities and apply risk-based testing practices to ensure safety and efficacy.

📜 Ensure testing activities adhere to FDA 21 CFR Part 820, ISO 13485, IEC 62304, and ISO 14971 standards.

🚀 Propose and implement improvements to verification processes, tools, and methodologies for enhanced outcomes.

🤝 Collaborate with AI, product management, and software teams to align requirements and testing scopes.

✅ Maintain robust traceability from requirements to test cases, ensuring all requirements are thoroughly verified.

What you’ll bring

🎓 Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related field.

🛠️ Experience with test management tools like Jira, Xray, or TestRail.

🛠️ Proficiency in cloud and web testing.

🛠️ Knowledge of scripting and automation tools (e.g., Python, DART & Flutter).

📚 Familiarity with medical device software standards, including FDA regulations, ISO 13485, and IEC 62304.

✍️ Exceptional skills in creating test cases, defect reports, and compliance-driven documentation.

💡 Strong analytical and problem-solving abilities.

💡 Excellent communication and collaboration skills to work across teams.

🏅 Software Testing Qualifications Board (or equivalent certifications) is a strong advantage.

Why join CergenX?

At CergenX, we believe innovation and patient safety go hand in hand. As part of our QA team, you’ll play a critical role in shaping technologies that impact lives worldwide. We offer a supportive environment for professional growth and the opportunity to work on meaningful projects in the health-tech space.

Ready to make a difference?

Apply now to join a team where your expertise will have a direct impact on healthcare innovation.