Senior QA Engineer

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. We provide a dynamic and collaborative work environment where you can grow your career and make a significant impact.

Job Description

We are seeking a highly meticulous and experienced Senior QA Engineer for a critical, regulated medical device project. This role is strictly focused on formal, structured manual verification and validation (V&V) activities, process design, and documentation integrity. 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.

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 full 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.

Practical application knowledge of risk management principles, as codified in ISO 14971.

Experience in a medical device development environment subject to FDA regulations (e.g., 21 CFR Part 820).

Additional Information

Location : Guadalajara, Jalisco, Mexico (working from home – office presence will be required occasionally).

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