Senior QA Engineer — MedTech (GxP) | Remote LATAM

Bridgenext; Argentina; Híbrido; ARS 105.638.000 - 150.912.000; Jornada completa

Descripción de la vacante

Bridgenext is seeking a Senior QA Engineer for its MedTech team, focused on quality, safety, and regulatory compliance of healthcare software solutions. The role emphasizes both manual and automated testing, with documentation validation and adherence to GxP standards.

You will design validation protocols, review documentation, and maintain audit-ready records while collaborating with Regulatory Affairs, QA, and engineering teams across LATAM.

Formación

• 5+ years of experience as a Quality Assurance Engineer in regulated environments.
• Domain knowledge in MedTech, HealthTech, Biotech, or Pharmaceutical industries.
• Strong hands-on experience validating documentation and software under GxP guidelines, ISO standards (13485/14971), or FDA compliance regulations.
• Advanced to Fluent English (written and spoken), C1/C2 level.
• Proficient in automation tools like Selenium, Cypress, Playwright, and API testing tools such as Postman, REST Assured.
• Excellent documentation and traceability skills using Jira, TestRail, Zephyr or similar.

Responsabilidades

• Validate and review technical documentation, test plans, RTMs, and validation protocols (IQ/OQ/PQ) per GxP standards.
• Develop and execute end-to-end test strategies for MedTech applications; design maintainable automation tests for API and UI.
• Lead cross-functional collaboration with Regulatory Affairs, Software Engineers, Product Managers, and QA managers; mentor junior engineers.

Descripción del empleo

Bridgenext is seeking a Senior QA Engineer for its MedTech team, focused on quality, safety, and regulatory compliance of healthcare software solutions. The role emphasizes both manual and automated testing, with documentation validation and adherence to GxP standards.

You will design validation protocols, review documentation, and maintain audit-ready records while collaborating with Regulatory Affairs, QA, and engineering teams across LATAM.