Senior QA Engineer (Manual & Automation) - MedTech

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

Company Overview

At Bridgenext, we engineer Growth Operating Systems. Most enterprises have spent millions on their revenue stack and still aren't seeing the growth they expected.They have tools that function, but no system that wins. We help growth-hungry companies close that gap by turning fragmented platforms, siloed teams, and disconnected data into one integrated Growth OS. More than a technology company or marketing agency, we're a global digital consultancy with experts in engineering, data, AI, creative and more.

Our teams are made up of experts who believe in engineering impact, starting with putting people at the center of everything we do. Every team member directly shapes our work, culture, and values. Nothing matters more to us than a kind, respectful, fulfilling environment that supports everyone. Our flexible, inclusive culture gives you the autonomy, resources, and opportunities to thrive.

Position Description

We are seeking a highly detail-oriented and experienced Senior QA Engineer to join our MedTech team. In this role, you will be responsible for ensuring the quality, safety, and compliance of our healthcare and medical technology software solutions.

Beyond hands-on manual and automated testing, a critical focus of this role involves rigorous documentation validation, process compliance, and adherence to GxP standards and medical device quality frameworks.

Key Responsibilities:

• Quality Assurance & Compliance (GxP Focus)
  • Perform thorough validation and review of technical documentation, test plans, requirements trace matrices (RTM), and validation protocols (IQ/OQ/PQ) in accordance with GxP (GCP, GMP, GLP) standards.
  • Ensure all software development and testing activities comply with healthcare regulatory standards such as FDA 21 CFR Part 11, ISO 13485, IEC 62304, and HIPAA.
  • Participate in regulatory compliance reviews, quality audits, and verification of standard operating procedures (SOPs).
  • Maintain comprehensive audit-ready documentation for all testing phases and defect lifecycles.
• Manual & Automated Testing
  • Design, develop, and execute end-to-end test strategies, test suites, and test cases for complex MedTech applications.
  • Establish and maintain maintainable, scalable automated test frameworks for API and UI testing (e.g., Cypress, Selenium, Playwright, or Postman).
  • Execute manual functional, non-functional, regression, integration, and risk-based testing where automated testing is not applicable or compliant.
  • Identify, document, prioritize, and track software defects, ensuring root-cause analysis is performed in line with compliance procedures.
• Collaboration & Leadership
  • Work closely with cross-functional teams including Software Engineers, Product Managers, Regulatory Affairs, and Quality Assurance Managers.
  • Mentor junior QA engineers and advocate for quality-first, compliance-driven engineering practices across the team.
  • Participatein Agile/Scrumceremonieswhilemaintainingthenecessarybalancebetweenagileagilityandstrictregulatorydocumentation.

Workplace: Remote / Hybrid role in LATAM, preferably in Argentina

Must Have Skills:

• Experience: 5+ years of experience as a Quality Assurance Engineer, with a proven track record in both manual and automated testing within regulated environments
• Domain Knowledge: Solid background in the MedTech, HealthTech, Biotech, or Pharmaceutical industry
• GxP & Regulatory Expertise: Strong hands-on experience validating documentation and software under GxP guidelines, ISO standards (13485 / 14971), or FDA compliance regulations
• English Proficiency: Advanced to Fluent English (written and spoken). Seeking level C1/C2 level fluency. Ability to write clear, compliant technical documentation and articulate QA/regulatory concepts effectively to international stakeholders
• Automation Skills: Proven experience with modern test automation tools/frameworks (e.g., Selenium, Cypress, Playwright) and API testing tools (Postman, REST Assured)
• Documentation & Traceability: Exceptional skill in writing structured test plans, test cases, execution reports, and maintaining traceability matrices
• Tools: Experience using issue-tracking and QA management tools such as Jira, TestRail, Zephyr, or similar

Professional Skills:

• Excellent analytical and problem-solving skills
• Strong communication and interpersonal skills
• Ability to work effectively in a fast-paced, dynamic environment
• Ability to Lead and Guide Discussions with Business Partners
• Confident and Proactive Nature
• Ability to understand scope and ask the right questions
• Organized, detail and process oriented
• Proven ability to build, manage and foster a team-oriented environment

Bridgenext is an Equal Opportunity Employer