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      Urgent! Senior QA Engineer Job Opening In Guadalajara – Now Hiring KMS Technology
 
                        
                         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.
 
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).
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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Unlock Your Senior QA Potential: Insight & Career Growth Guide
Real-time Senior QA Jobs Trends in Guadalajara, Mexico (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Senior QA in Guadalajara, Mexico using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 9246 jobs in Mexico and 360 jobs in Guadalajara. This comprehensive analysis highlights market share and opportunities for professionals in Senior QA roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! KMS Technology is currently hiring and seeking a Senior QA Engineer to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at KMS Technology adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Senior QA Engineer Jobs Mexico varies, but the pay scale is rated "Standard" in Guadalajara. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Senior QA Engineer typically include Computer Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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