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).

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