Quality Assurance (QA) Engineer

Eyes of AI; United States; Remote; AUD 60,000 - 119,000; Part time

Job summary

Eyes of AI is seeking a QA Engineer to own the end-to-end testing lifecycle for our AI-powered product suite in a remote-capable role. You will ensure quality, safety, and regulatory compliance under an ISO 13485 / MDR-aligned QMS.

You will design and maintain test plans, execute both manual and automated tests, and develop V&V artefacts to support audits and submissions. Prior experience with AI/ML testing is highly valued.

Qualifications

• 5+ years of manual and automated QA experience in regulated environments.
• Experience with ISO 13485, MDR or similar compliance is highly preferred.
• Proven ability to write and execute test plans, cases, and reports.
• Knowledge of V&V concepts and regulatory artefact creation.

Responsibilities

• Own QA activities within ISO 13485/MDR-aligned QMS and release processes.
• Design, execute, and maintain test plans, cases, and automation for cloud and desktop apps.
• Develop verification and validation artefacts for regulatory submissions and audits.
• Translate requirements into testable criteria with Product, Clinical, and Regulatory teams.
• Lead regression, performance, and basic security testing; prepare release readiness.

Skills

QA experience

Manual testing

Automated testing

API testing

CI/CD

Web app testing

Model verification

Education

Bachelor's degree in Computer Science, Engineering, Information Technology, or equivalent

Tools

Puppeteer

Cypress

Playwright

pytest

Postman

Bitbucket

Job description

The Quality Assurance (QA) Engineer ensures that Eyes of AI's AI-powered product suite meets the highest standards of quality, safety, and regulatory compliance. This role owns the end-to-end testing lifecycle across online and offline applications, including AI model verification, within an ISO 13485 / MDR-aligned Quality Management System (QMS).

Key Responsibilities

• Own QA activities within the ISO 13485 / MDR-aligned QMS, including release/change control, nonconformance, CAPA, and QA-related document control.
• Design, execute, and maintain test plans, test cases, and test automation for online (cloud) and offline (desktop) applications, including AI model verification and validation.
• Develop and maintain verification and validation (V&V) artefacts (test protocols, test reports, traceability matrices) to support regulatory submissions and audits.
• Translate intended use, Instructions for Use (IFU), and product requirements into clear, testable requirements and acceptance criteria in collaboration with Product, Clinical, and Regulatory teams.
• Set up, manage, and maintain test environments and perform regression, performance, and basic security testing.
• Lead and document release readiness reviews, including risk-based test planning and execution for new features, hotfixes, and post-market amendments
• Ensure bi-directional traceability between requirements, risk controls, test cases, and test evidence in alignment with the QMS and applicable standards.
• Draft, review, and maintain QA documentation (test plans, SOPs, work instructions, checklists, reports) and ensure readiness for internal and external audits.
• Support continuous improvement of QA tools, metrics, and processes; coach engineers on testing and quality best practices within a regulated environment.
• Collaborate closely with Engineering, DevOps, ML, Product, and Regulatory/Quality teams to embed quality throughout the software development lifecycle.

Qualifications & Experience

• 5+ years of hands-on manual and automated QA experience, including test planning, execution, and defect management.
• 2-3+ years of experience in regulated medical device software, healthcare products, or other safety-critical domains.
• Practical skills with manual and automated testing tools (e.g. Puppeteer, Cypress, Playwright, pytest), defect tracking and test management tools, and CI/CD environments (e.g. Bitbucket).
• Experience testing modern web apps (e.g. Angular/React, Node.JS/Laravel/Python)
• Strong API testing experience (e.g. Postman)
• Demonstrable experience working within an ISO 13485-compliant QMS or contributing evidence for EU MDR, TGA, or FDA audits/submissions.
• Strong understanding of software V&V, working knowledge of ISO 14971 risk management principles and processes, and traceability matrices across the lifecycle.
• Experience testing both cloud and desktop applications;
• Familiarity with AI/ML system testing, including model validation, dataset handling, performance metrics, and monitoring, is highly desirable.
• Clear and structured written communication skills for authoring regulatory-grade artefacts, SOPs, and test reports.
• Bachelor's degree in Computer Science, Engineering, Information Technology, or equivalent practical experience.

Job Type: Part-time

Pay: $30.00 - $60.00 per hour

Work Location: Remote