Software QA Manager

Purpose

The Software QA Manager will lead our Quality Assurance team to ensure the delivery of safe, high-quality software products compliant with medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820). This hands-on leadership role involves developing QA strategies, driving test automation, and embedding quality practices throughout the SDLC. The ideal candidate combines technical expertise in test automation with experience in regulated environments and a passion for mentoring teams.  

Responsibilities

• Define and implement scalable QA processes aligned with medical device standards (ISO 14971, IEC 62304).  
• Lead and mentor a team of QA engineers, fostering a culture of quality ownership.  
• Hands-on leadership: Develop test cases, review scripts, and ensure requirements traceability.  
• Drive metrics-based improvements in test coverage, automation, and defect prevention.  
• Oversee end-to-end testing (functional, regression, performance, security, and usability).  
• Ensure rigorous documentation for audits (test plans, cases, reports).  
• Manage both manual and automated testing, with a focus on risk-based testing for compliance.  
• Participate in defect triage and resolution with cross-functional teams.  
• Scale test automation using Cypress, Selenium, and API testing tools.  
• Evaluate and integrate QA tools into CI/CD pipelines (Jenkins/Bitbucket Pipeline).  
• Champion shift-left testing and continuous quality in Agile/DevOps workflows.  
• Partner with Product, DevOps, and Regulatory Affairs to ensure compliance and timely releases.  
• Act as the QA voice in Agile ceremonies (sprint planning, retrospectives).  
• Review requirements and designs for testability and regulatory alignment.  
• Maintain compliance with ISO 13485, FDA QSR, HIPAA, and GDPR.  
• Conduct risk assessments and mitigation planning per ISO 14971.  
• Lead root cause analysis (RCA) for critical issues and CAPA processes.  

Qualifications

• Bachelor’s degree in Computer Science, Engineering, or related field.  
• 5+ years in QA, including 2+ years in a leadership role  
• Expertise in test automation (Cypress, Selenium, Postman) and CI/CD pipelines.  
• Proficiency in JavaScript/Python for test scripting.  
• Agile/Scrum experience with tools like JIRA.  
• Strong leadership and collaboration skills.  
• Analytical problem-solver with meticulous attention to detail.  
• Ability to balance speed and compliance in a fast-paced environment.  

Preferred Qualifications

• Experience with performance/load testing.  
• Knowledge of cloud platforms (AWS/Azure, Azure, GCP) and security testing (penetration testing).  

Salary & Benefits

The estimated hiring salary range for this position is $165,000-$185,000 * The actual salary will be based on a variety of job-related factors, including geography, skills, education and experience. The range is a good faith estimate and may be modified in the future. This role is also eligible for a range of benefits including medical, dental and 401K retirement plan.