Senior QA Engineer – Lead Test Strategy for Life-Critical Software

Requirements

Key Responsibilities

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  Define and execute test strategies and risk-based test plans for complex, multi-platform systems.

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  Ensure traceability and compliance from requirements through execution, aligned to FDA and HIPAA standards.

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  Lead functional, regression, integration, and exploratory testing across mobile, web, and backend systems.

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  Coordinate with DevOps and Automation Engineers to embed quality gates into CI/CD.

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  Maintain high-quality test documentation — test plans, cases, execution logs — to support regulatory audits.

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  Provide QA sign-offs and own release validation in tight, Agile sprints.

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  Represent QA in sprint ceremonies, design reviews, and retrospectives.

Must-Have Skills

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  5+ years in QA/test engineering, with deep experience in regulated domains (healthcare, fintech, aerospace).

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  Strong expertise in designing and managing manual test suites for complex apps (React, Flutter, APIs).

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  Experience with test case management tools (TestRail, Zephyr), bug tracking (Jira), and source control (Git).

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  Solid understanding of SDLC, Agile, and traceability practices for compliance workflows.

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  Strong communication and leadership skills — able to influence across product, dev, and compliance teams.

Nice-to-Have

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  Familiarity with BDD frameworks (Cucumber, Gherkin).

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  Exposure to FDA 21 CFR Part 11, HIPAA, or ISO 13485 documentation.

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  Basic automation knowledge or collaboration with automation teams (e.g., Cypress, Appium).

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  Experience validating mobile apps, backend systems, and API integrations.