Jobs → QA & Testing → Software Quality Engineer

About the Role We are seeking an experienced Software Quality / Product Quality Engineer to manage software product issues, coordinate defect investigations, and support risk management in a regulated medical device environment. This is a 12-month contract position based in Raleigh, NC, with a hybrid work model (3 days onsite, 2 days remote). Key Responsibilities • Own and coordinate software backlogs and product issue management • Investigate software and product defects, identifying root cause, impact, severity, affected users, systems, and versions • Coordinate with cross-functional teams, including Systems, Quality, Regulatory, Medical Affairs, Engineering, Sales, Service, and Operations • Manage issue triage and maintain accurate, auditable quality records in JIRA • Ensure duplicate issues are closed with proper documentation and unique issues receive complete investigations • Assess product risks and safety impacts, escalating safety-critical issues for field-action or nonconformance review • Track investigations, corrective actions, and project deliverables to ensure timely completion within budget Requirements • Bachelor’s degree in Engineering or a related field, or equivalent experience • 5+ years of relevant experience • Experience in a regulated industry; medical devices, pharmaceuticals, or automotive preferred • Strong knowledge of quality engineering, risk management, software, requirements, and testing • Proficiency in JIRA and Microsoft Office • Excellent written and verbal communication, analytical thinking, and problem-solving skills • Strong ownership, organization, prioritization, and cross-functional coordination abilities • Ability to work independently and manage multiple priorities