Medical Device QA & Validation Tester

Abbott Laboratories; Bogotá; Presencial; COP 100.440.000 - 167.400.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development with an国际 company

Great place to work globally

Diversity recognition

Descripción de la vacante

Abbott in Bogotá, Colombia, seeks a Quality Assurance Tester Specialist to validate digital solutions in a regulated medical device environment and support testing across the global organization.

You will execute test plans, assist test automation, participate in audits, and ensure Design History File integrity while collaborating with R&D, Quality, and Regulatory teams. Strong English and analytical skills required.

Formación

• Bachelor's degree in a technical field.
• 5+ years of experience authoring and executing software test cases and validation activities.
• Experience leading User Acceptance Testing (UAT) activities.
• Experience creating test plans, test scripts, and test documentation.
• Knowledge of Design Controls, Verification & Validation processes, and software development practices.
• Strong troubleshooting, analytical, and problem-solving skills.
• Ability to work collaboratively across multiple functions and stakeholders.
• Advanced English proficiency (written and verbal).

Responsabilidades

• Execute and support the timely completion of Quality Engineering deliverables, including manual test plans, test scripts, automated testing activities, and test reports.
• Support the design and development of test automation frameworks for web and OTA applications.
• Support the execution of Quality Plans and Verification & Validation (V&V) testing activities.
• Participate in root‑cause investigations and resolution activities in partnership with cross‑functional teams.
• Support product Risk Management and Design Verification and Validation activities.
• Contribute to internal and external audits, including preparation of documentation and responses.
• Support the definition of measurable, verifiable customer and product requirements.
• Create and manage testing schedules and work plans while ensuring timely completion of assigned deliverables.
• Review Document Change Requests, test protocols, and test results provided by other functional teams.
• Participate in reviews of system and software requirements, software and firmware designs, and code inspections using static testing and TDD practices.
• Collaborate with R&D Engineering, Operations, Quality, Clinical, and Regulatory Affairs teams to support product development and compliance efforts.
• Ensure Design History File (DHF) content integrity and compliance with applicable regulatory and quality standards.
• Help improve software quality processes and testing tools throughout the software development lifecycle.

Conocimientos

Test planning

UAT leadership

Test script creation

Troubleshooting

Cross-functional collaboration

English proficiency

Educación

Bachelor's degree in Computer Science, Software Engineering, Systems Engineering, Information Technology, or a related technical field

Descripción del empleo

Abbott in Bogotá, Colombia, seeks a Quality Assurance Tester Specialist to validate digital solutions in a regulated medical device environment and support testing across the global organization.

You will execute test plans, assist test automation, participate in audits, and ensure Design History File integrity while collaborating with R&D, Quality, and Regulatory teams. Strong English and analytical skills required.