Senior QA Engineer

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 wont be mandatory all the time rather it will required from time to time).

Remote Work :

No

Employment Type :

Full-time