Senior Software Quality Assurance Engineer (MedTech)

TL;DR

Senior Software Quality Assurance Engineer (MedTech): Supporting quality activities across multiple software products in a compliance-focused environment with an accent on laboratory workflows and clinical algorithm validation. Focus on performing functional, integration, and regression testing while ensuring adherence to FDA, HIPAA, and CLIA regulatory standards.

Location: Must be in commutable driving distance to Brisbane, CA

Salary: $112,000 - $140,000 USD

Company

hirify.global is a leading precision medicine solutions company focused on providing genomics-based information and digital healthcare solutions for transplant patients.

What you will do

• Perform functional, integration, regression, and end-to-end testing for software supporting laboratory workflows.
• Execute software verification and validation for clinical algorithms to ensure correctness and regulatory compliance.
• Develop detailed test plans, test cases, and traceability documentation in alignment with QMS requirements.
• Review functional and technical specifications to identify risks and contribute to mitigation plans.
• Collaborate with software engineering, product, and regulatory teams to ensure release goals are met.
• Support release planning and participate in quality gate reviews with detailed risk assessments.

Requirements

• Bachelor’s or Master’s degree in Computer Science or equivalent.
• 5+ years of experience in Software Quality Assurance Engineer roles.
• 5+ years of experience testing LIMS, laboratory workflows, or reference lab data systems.
• Strong understanding of SDLC, software validation, and release management.
• Proficiency with backend testing and SQL query development.
• Experience operating in HIPAA, CLIA, or FDA-regulated environments.

Nice to have

• Hands-on automation experience using automated testing tools.
• Familiarity with CI/CD pipelines and version control systems.
• Experience with test management tools like Jira, TestRail, or Jama.
• Familiarity with transplant or reference lab environments.

Culture & Benefits

• Competitive base salary and incentive compensation.
• Comprehensive health and welfare benefits including gym reimbursement.
• 401(k) savings plan with company match.
• Employee Stock Purchase Plan and pre-tax commuter benefits.
• Living Donor Employee Recovery Policy offering up to 30 days of paid leave.