Senior QA Engineer

hace 4 semanas


Guadalajara, México KMS Technology A tiempo completo

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. We provide a dynamic and collaborative work environment where you can grow your career and make a significant impact.**Responsibilities**:**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.**Verification and Validation (V&V) Execution**:- 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.**Traceability and Compliance**:- 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 (Quality Management)** and** ISO 14971 (Risk Management)** principles, and meet relevant FDA medical device regulations.**Qualifications**:**Required Experience & Skills**:- Minimum of **5+ years**of dedicated experience in a QA or V&V role within a highly structured or regulated industry (e.g., medical devices, aerospace, pharmaceuticals, or defense).- ** 3+ years** of experience specifically operating as a Senior QA Engineer, Lead QA, or managing a small V&V effort.- Expert proficiency in **manual testing** methodology, formal test case design, and systematic test execution.- Exceptional attention to detail, strong process discipline, and deep expertise in documentation and** traceability management.**- Demonstrated ability to write clear, unambiguous, and defensible V&V documentation (e.g., protocols, summaries, and reports).- Strong verbal and written communication skills for cross-functional collaboration and documentation review.**Preferred Technical Background (Highly Desired)**:- Direct professional experience working within a quality management system governed by **ISO 13485** or strong familiarity with the requirements of **ISO 9001.****Benefits and Perks**:**Location**:Guadalajara,**Jalisco, Mexico (working from home - office won't be mandatory all the time, rather it will required from time to time).


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