Software Quality Engineer(Medical Devices)

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.

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.

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements: Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums. Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided. Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.