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# Software Quality Engineer(Medical Devices)

- **Company:** Intellectt, Inc
- **Location:** United States (Remote available)
- **Experience:** Expert
- **Salary:** $72,800 - $83,200
- **Contract:** Permanent contract
- **Skills:** JIRA, Software Quality, Microsoft Office, Software Engineering
- **Published:** October 31, 2026
- **Apply:** https://www.careerbuilder.com/job-details/software-quality-engineer-medical-devices-nc--86c0c2a6-b42c-4862-80e5-b2dd4cc44590

## About the Role

Quality Engineering, Medical Equipment, Software Engineering, Quality Engineering, Medical Equipment, Software Engineering, Organizational Skills, Product Backlog, Quality Management, Corrective and Preventative Action (CAPA) Systems, * Bachelor's degree in Engineering, a related field, or equivalent experience.

 * 5+ years of relevant professional experience.
 * Experience in a regulated industry such as Medical Devices, Pharmaceuticals, or Automotive.
 * Strong understanding of software quality, product quality, risk management, requirements, and testing.
 * Experience with CAPA, defect investigation, root cause analysis, and issue management.
 * Proficiency with JIRA and Microsoft Office applications.
 * Excellent written and verbal communication skills.
 * Strong analytical, critical-thinking, organizational, and project coordination abilities.
 * Ability to work independently and manage multiple priorities.
 * Must be comfortable working onsite in NC, three days per week.

## Description

The Client is seeking an experienced Software Quality Engineer to manage software product issues, coordinate defect investigations, and oversee quality backlog activities within a regulated medical device environment. The ideal candidate will have strong experience in software quality, product issue management, risk assessment, CAPA, and cross-functional coordination., * Own and coordinate software quality backlogs and product issue management for assigned products.

 * Investigate software and product defects, identify root causes, and assess severity, impact, affected users, systems, and software versions.
 * Coordinate with cross-functional teams, including Systems, Quality, Regulatory, Medical Affairs, Engineering, Sales, Service, and Operations.
 * Manage issue triage and tracking through JIRA, ensuring duplicate issues are closed and unique issues are properly investigated and documented.
 * Assess product risks and safety impacts, escalating safety-critical issues for field-action or nonconformance review.
 * Ensure investigations, corrective actions, and project deliverables are completed on time and within budget.
 * Maintain accurate, complete, and auditable quality records.
 * Communicate investigation findings and project updates clearly to relevant stakeholders.