Senior QA Engineer – Lead Test Strategy for Life-Critical Software
Job Summary
Job Description
- 5+ years QA/test engineering experience in regulated domains.
- Design and manage manual test suites for complex apps.
- Experience with test case management, bug tracking, and source control.
- Solid understanding of SDLC, Agile, and traceability.
- Strong communication and leadership skills.
- Familiarity with BDD frameworks (Cucumber, Gherkin).
- Exposure to FDA 21 CFR Part 11, HIPAA, or ISO 13485.
- Basic automation knowledge or collaboration with automation teams.
- Experience validating mobile apps, backend systems, and API integrations.
- Competitive salary
- Bonus incentives
- Leadership pathways
- Collaborate with world-class engineers
- Elevate QA to a strategic discipline
17 skills required
Job Details
Senior QA Engineer – Lead Test Strategy for Life-Critical Software
Why You’ll Love It:
Lead from the trenches — drive test planning, coverage, and compliance readiness across cross-functional teams.
Critical domain mastery — work hands-on in healthcare, where precision QA translates to real-world safety.
Code-first culture — collaborate with automation teams to embed test coverage into CI/CD pipelines and shift-left architectures.
Mentor & uplift — coach junior testers on documentation standards, domain modeling, and edge-case thinking.
Fast-track your future — grow into test strategy, automation leadership, or regulatory engineering.
Requirements
Key Responsibilities
Define and execute test strategies and risk-based test plans for complex, multi-platform systems.
Ensure traceability and compliance from requirements through execution, aligned to FDA and HIPAA standards.
Lead functional, regression, integration, and exploratory testing across mobile, web, and backend systems.
Coordinate with DevOps and Automation Engineers to embed quality gates into CI/CD.
Maintain high-quality test documentation — test plans, cases, execution logs — to support regulatory audits.
Provide QA sign-offs and own release validation in tight, Agile sprints.
Represent QA in sprint ceremonies, design reviews, and retrospectives.
Must-Have Skills
5+ years in QA/test engineering, with deep experience in regulated domains (healthcare, fintech, aerospace).
Strong expertise in designing and managing manual test suites for complex apps (React, Flutter, APIs).
Experience with test case management tools (TestRail, Zephyr), bug tracking (Jira), and source control (Git).
Solid understanding of SDLC, Agile, and traceability practices for compliance workflows.
Strong communication and leadership skills — able to influence across product, dev, and compliance teams.
Nice-to-Have
Familiarity with BDD frameworks (Cucumber, Gherkin).
Exposure to FDA 21 CFR Part 11, HIPAA, or ISO 13485 documentation.
Basic automation knowledge or collaboration with automation teams (e.g., Cypress, Appium).
Experience validating mobile apps, backend systems, and API integrations.
Benefits
- Competitive salary, bonus incentives, and leadership pathways.
Collaborate with world-class engineers building systems where failure is not an option.
Elevate QA to a strategic discipline — apply now to build software that earns trust at global scale.
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