Company Description At KMS Technology, we are dedicated to delivering cutting-edge solutions and services that empower businesses to achieve their goals. Our team is composed of highly skilled professionals who are passionate about technology and innovation. Job Description We are seeking a highly meticulous and experienced Senior QA Engineer to serve as a Team Lead for a critical, regulated medical device project. The successful candidate will own the quality assurance lifecycle, ensuring absolute traceability between requirements, design, and executed tests, and will guide junior QA resources. This is not a software development or test automation role ; proficiency lies in quality systems and rigorous documentation under a regulated framework. Responsibilities: Process Leadership & Mentorship: Act as the primary owner of the test execution and documentation process, ensuring all activities adhere to the Quality Management System (QMS). Lead and mentor junior QA specialists, providing guidance on test case writing, execution standards, and documentation practices.



Collaborate closely with Engineering, Project Management, and Regulatory Affairs teams to align V&V; activities with project timelines and compliance mandates. Design, develop, and execute comprehensive manual test plans, test protocols, and detailed test cases based on finalized design specifications and user needs. Perform formal verification and validation testing, meticulously recording results using established QMS templates and documentation standards. Manage the review and approval process for all V&V; documentation, including Test Reports. Establish and maintain f ull requirements-to-design-to-test traceability matrices to demonstrate complete coverage of all functional and non-functional specifications. Identify, document, and manage defects (deviations), ensuring thorough root cause analysis and verification of fixes before closure. Ensure all QA activities are executed in alignment with ISO 13485

📌 Senior QA Engineer (Guadalajara)
🏢 KMS Technology
📍 Guadalajara