Bluedrop Medical is revolutionizing diabetic foot care through its patented system designed to reduce the risk of diabetic foot ulcers. With nearly half a billion diabetics globally, up to 25% face the risk of developing foot ulcers, which may lead to severe complications such as infections and amputations. By integrating advanced detection technology with the internet of things, Bluedrop Medical offers a connected health solution to identify ulcers at early stages, enabling effective and cost-efficient treatment. The company is committed to improving patient outcomes by blending cutting‑edge technology with compassionate care.
Role Description
We are seeking a talented and experienced Senior Software QA Engineer to join our dynamic team. As a Senior QA Engineer, you will play a pivotal role in ensuring the quality, reliability, and regulatory compliance of our software solutions. The ideal candidate will have a strong background in software quality assurance within medical device or regulated software environments, with expertise in test strategy, automation frameworks, and quality management systems.
Responsibilities
Quality Assurance & Test Strategy
Define, own and execute a comprehensive QA strategy covering unit, integration, system, and end‑to‑end testing across cloud‑based and embedded software components.
Develop and maintain automated test suites using industry‑standard frameworks, ensuring broad regression coverage.
Design and execute risk‑based testing approaches aligned with IEC 62304 and ISO 14971 requirements for medical device software.
Establish and maintain traceability between software requirements, design, and test artefacts.
Work closely with cross‑functional teams including software engineers, product managers, regulatory affairs, and clinical stakeholders to embed quality throughout the development lifecycle.
Participate in design reviews, code reviews, and agile ceremonies to provide QA input at every stage.
Act as the quality advocate within the engineering team, promoting a shift‑left testing culture.
Technical Leadership
Provide QA leadership and mentorship, raising the quality engineering capability across the team.
Contribute to the selection and adoption of test tooling, CI/CD pipeline integration, and quality metrics.
Champion best practices in Test‑Driven Development (TDD) and Behaviour‑Driven Development (BDD) and implement TDD and BDD to ensure the reliability and maintainability of the codebase.
Develop and maintain automated unit tests, integration tests, and end‑to‑end tests for event‑driven system.
Regulatory & Compliance
Support preparation and review of software‑related documentation for regulatory submissions (e.g., FDA, CE/MDR).
Maintain and improve the Software Quality Management System (QMS) processes in line with applicable standards.
Participate in internal audits and support external regulatory inspections as required.
Monitor quality metrics, defect trends, and test coverage data to drive continuous improvement.
Stay current with evolving standards, tools, and best practices in medical device software QA.
Identify and drive process improvements that increase efficiency and product quality.
Requirements
Technical Skills
Proven experience as a Software QA Engineer in a regulated software or medical device environment.
Strong expertise in test automation frameworks, with hands‑on experience in Playwright. Familiarity with other frameworks such as Selenium, Cypress, or Robot Framework is a plus.
Solid understanding of software testing methodologies: unit, integration, system, regression, performance, and exploratory testing.
Familiarity with event‑driven architectures, microservices, and cloud‑based systems (experience testing APIs and backend services essential), SaaS, microservices, docker, K8s, Google Cloud.
Experience with CI/CD pipelines, particularly GitLab CI, and integrating automated tests into the build pipeline.
Regulatory & Standards Knowledge
Working knowledge of IEC 62304 (Medical Device Software Lifecycle) and ISO 14971 (Risk Management).
Familiarity with FDA 21 CFR Part 11, EU MDR, or equivalent regulatory frameworks is highly desirable.
Experience maintaining or contributing to a QMS (e.g., document control, CAPA, audit readiness).
Development Practices
Experienced in Agile/Scrum delivery and embedding QA into sprint workflows.
Comfortable working with GitLab for version control, merge requests, and issue tracking.
Able to write clear, maintainable test plans, test cases, and QA documentation.
Strong communication and stakeholder management skills.
Ability to clearly articulate quality risks and their business impact to both technical and non‑technical audiences.
Education & Experience
Bachelor’s or Master’s degree in Computer Science, Engineering, or a related field.
5+ years of relevant QA experience, with at least 2 years in a regulated or medical device software context.
Nice to Have
ISTQB certification or equivalent quality engineering qualification.
Experience testing front‑end applications built with VueJS or similar frameworks.
Background in the healthcare or digital health domain.
Proficiency with Google Cloud Platform (GCP) and cloud‑native testing approaches.
Experience with performance/load testing tools (e.g., k6, Gatling, Locust).
Exposure to the Zoho suite of tools (e.g., Zoho Projects, Zoho Desk, Zoho Analytics) and experience integrating these into QA or product workflows.
Experience leveraging AI and AI‑powered toolsets to accelerate QA activities, such as AI‑assisted test case generation, intelligent test maintenance, and defect prediction. Hands‑on experience with Claude Code is particularly valued, as is familiarity with other AI‑assisted development tools to enhance testing efficiency and coverage.
About Bluedrop Medical
Bluedrop Medical is an early‑stage cloud‑based diagnostic medical device company based in Galway, Ireland. Our remote sensing and data analytics technology has the potential to reduce mortality, improve quality of life, and reduce costs for millions of patients worldwide.
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