MedTech QA Engineer - Manual & Automated (Remote LATAM)

UNAVAILABLE; Argentina; Híbrido; ARS 105.638.000 - 196.185.000; Jornada completa

Descripción de la vacante

Bridgenext is seeking a Senior QA Engineer to join its MedTech team. You will ensure quality, safety, and regulatory compliance for healthcare software, driving documentation validation and robust testing across manual and automated pipelines.

Lead QA efforts, collaborate with cross-functional teams, and maintain audit-ready records while aligning with GxP standards and ISO/federal regulations. Remote/hybrid LATAM role, preferably in Argentina.

Formación

• 5+ years of experience as a Quality Assurance Engineer in regulated environments
• Solid background in MedTech/HealthTech/Biotech/Pharmaceutical industries
• GxP validation of documentation and software with ISO 13485/14971 or FDA compliance
• Advanced to Fluent English (C1/C2)
• Experience with modern test automation and API testing tools
• Excellent documentation and traceability skills
• Ability to lead and mentor QA teams

Responsabilidades

• Validate and review technical docs, test plans, RTMs, IQ/OQ/PQ protocols per GxP
• Ensure compliance with FDA 21 CFR Part 11, ISO 13485, IEC 62304, HIPAA
• Design and execute end-to-end test strategies for MedTech apps
• Develop maintainable automated test frameworks for API and UI
• Perform manual functional, regression, integration, and risk-based testing
• Document defects and perform root-cause analysis

Conocimientos

QA Engineering

Manual Testing

Automation Testing

Documentation

Regulatory Compliance

Leadership

Agile/Scrum

Regulatory Affairs

English Proficiency

Test Automation Tools

Herramientas

Selenium

Cypress

Playwright

Postman

REST Assured

Jira

TestRail

Zephyr

Descripción del empleo

Bridgenext is seeking a Senior QA Engineer to join its MedTech team. You will ensure quality, safety, and regulatory compliance for healthcare software, driving documentation validation and robust testing across manual and automated pipelines.

Lead QA efforts, collaborate with cross-functional teams, and maintain audit-ready records while aligning with GxP standards and ISO/federal regulations. Remote/hybrid LATAM role, preferably in Argentina.