Director of Quality Assurance

Job not on LinkedIn

🔥 7 minutes ago

🇺🇸 United States – Remote

💵 $185k - $205k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Medrio

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $30M Venture Round on 2017-05

Healthcare • Consulting • Logistics

Medrio is a company that specializes in providing advanced technology solutions for clinical trials. They offer a range of services including Clinical Data Management Systems (CDMS/EDC), electronic Clinical Outcome Assessments (eCOA/ePRO), eConsent, and Randomization and Trial Supply Management (RTSM). Medrio's integrated platform allows for efficient data collection and management, optimizing workflows and enhancing participant engagement during clinical research. The company's solutions cater to various industries such as MedTech, Pharma & Biotech, and Clinical Research Organizations (CROs).

📋 Description

• Lead the QA organization through transformation to an AI-optimized SDLC • Define the overarching quality strategy and integrate AI tools across the SDLC • Scale automated, resilient testing frameworks for multiple product launches and continuous feature delivery • Lead AI-assisted test case creation, requirements analysis, and automated risk-based test coverage • Scale quality output and monitor release cycle time, escaped defect rate, automated test coverage, and regression suite runtime • Oversee automated testing strategies for a multi-tenant SaaS platform, including Playwright and AI-powered self-healing test infrastructure • Manage tenant isolation, data-segregation testing, configuration-driven test matrices, and shared-schema regression risk • Direct QA organization activities and maintain platform stability and quality engineering standards • Ensure QA practices, documentation, and evidence meet HIPAA, 21 CFR Part 11, GxP/CSV, SOC 2, and GDPR requirements where applicable • Support internal and customer audits as a senior quality representative • Own review, approval, and evidence framework for AI-assisted test artifacts • Partner with Security and DevOps on SAST/DAST, dependency and vulnerability triage, penetration testing, and PHI de-identification • Lead distributed in-house and vendor QA teams across time zones and maintain vendor partnerships • Execute strategic roadmaps and improve quality-function cost and efficiency • Own quality plans for concurrent product launches and continuous SaaS releases, including release trains, phased rollouts, feature flags, and release-readiness criteria • Recruit, mentor, and upskill QA leaders and engineers • Monitor bugs and defects, establish continuous improvement loops, and report data-driven quality metrics • Manage the QA budget and support financial planning and resource forecasting • Work with Medrio customers and Development, Product, Support, Compliance, Sales, Professional Services, and Executive teams

🎯 Requirements

• BS in Computer Science, Computer Engineering, or a related field, or equivalent combination of education and experience • 10+ years of QA experience • 5+ years of management experience at a Director level or equivalent senior leadership position • Experience working within a regulated, compliant SDLC in healthcare or life sciences, with HIPAA and 21 CFR Part 11 exposure • Direct experience building and leading QA for a multi-tenant SaaS product • Demonstrated experience introducing AI-assisted testing into an established organization • Demonstrated experience implementing AI tooling across the SDLC, including AI-assisted test generation and self-healing test runners • Experience with Playwright at scale in CI and modern web and API automation, including contract and API testing • Judgment about where AI is and is not appropriate in a validated environment • Comprehensive understanding of the full Software Development Life Cycle and Agile and DevOps CI/CD pipelines • Demonstrated ownership of quality practices in a regulated healthcare setting, including validation, traceability, and audit evidence • Ability to work with and manage offshore teams, in-house employees, contractors, QA vendors, and external partners • Excellent executive communication skills and experience reporting metrics and strategic progress to C-level stakeholders • Strong attention to detail and commitment to compliance, documentation, and execution standards • Position is remote; US-based preferred • Ability to work across multiple time zones • Some travel may be required

🏖️ Benefits

• Medical, dental, vision, and life/LTD insurance • 100% of employees’ health insurance premiums covered • 50% of dependent premiums covered • Flexible work schedules and locations • Work/life balance • Weekly company-wide standup