QA Engineer

Kivo•Portland, OR

1d•Hybrid

About The Position

As a QA Engineer at Kivo, you own the full testing lifecycle, spanning manual exploratory testing, automated test suites, and 21 CFR Part 11 validation, to ensure the platform meets the highest standards of quality and compliance. You translate product requirements into comprehensive test coverage, validate new features against acceptance criteria, and continuously expand automation to scale with a rapidly evolving product. Your work is central to every release, connecting engineering and product teams, driving quality from sprint planning to final release sign-off, and shipping software that clients can trust. About Kivo Kivo is a modern cloud-based platform that helps life sciences teams manage regulated content across clinical, quality, and regulatory workflows. We’re powering the next generation of biotech with a product that’s intuitive, compliant, and ready to scale.

Requirements

Bachelor’s degree (or equivalent experience).
3-5+ years of experience in quality assurance, with a demonstrated focus on test automation.
Hands-on experience with test automation frameworks and tools (e.g., Playwright, Selenium, Cypress, Appium, Datadog, Ghost Inspector).
Experience with scripting languages such as JavaScript, Typescript, or Python.
Proven ability to translate requirements into thorough, traceable test coverage, and participation in release sign-off.
Strong sense of ownership and initiative, with the ability to work independently across multiple priorities without requiring close supervision.
Strong understanding of software development life cycle (SDLC) and quality assurance methodologies.
Proficiency in developing and maintaining test automation scripts.
Experience with version control systems (e.g., Git).
Experience with test management tools such as Jira, Zephyr, TestRail, or similar.
Excellent analytical, troubleshooting, and problem-solving skills.

Nice To Haves

Familiarity with validation processes and regulatory requirements (e.g., 21 CFR Part 11) is a plus.

Responsibilities

Automation Framework Development
Design, develop, and maintain test automation frameworks for functional, regression, performance, and end-to-end testing.
Write reusable, modular, and robust automation scripts using tools such as Playwright, Selenium, or other relevant technologies.
Test Strategy and Planning
Collaborate with product, development, and QA teams to understand project requirements and define testing strategies.
Review user stories, acceptance criteria, and business requirements to create detailed test plans, test cases, and traceability matrices.
Participate in sprint planning, backlog grooming, story refinement, and risk assessments to provide QA input early in the development cycle.
Feature Verification and Release Readiness
Verify new features and enhancements against defined acceptance criteria in collaboration with product owners and developers before release sign-off.
Conduct regression testing to confirm new changes do not break existing functionality.
Partner with product owners to clarify ambiguous acceptance criteria and flag gaps early in the development life cycle.
Maintain traceability between requirements, acceptance criteria, test cases, and test results.
Provide go/no-go input for releases based on test outcomes and outstanding defect severity.
Execution and Reporting
Execute automated test scripts to validate product functionality, performance, scalability, and reliability.
Analyze test results and work closely with developers to resolve defects efficiently.
Generate detailed test reports, track issues, and provide feedback on product quality and readiness for release.
Perform exploratory testing on new functionality to identify edge cases beyond defined acceptance criteria.
Validation Activities
Ensure that products comply with relevant regulatory and industry standards (e.g., FDA, ISO, CE).
Perform validation protocols (IQ, OQ, PQ) and ensure that validation documentation is complete, accurate, and compliant.
Execute User Acceptance Testing post-release, and finalize release validation.
Produce a client-facing validation documentation package for every software release.
Continuous Improvement
Identify opportunities to enhance automation and validation processes.
Stay updated with the latest automation tools, techniques, and best practices.
Optimize test environments, reduce test execution time, and expand test coverage.