Software Quality Engineer(Medical Devices)

Software Quality Engineer (Medical Devices)

Job Title: Software Quality Engineer (Software Product / Quality Backlog Coordinator)
Location: NC Hybrid (3 days onsite, 2 days remote)
Duration: 12 Months
Employment Type: Contract (W2)

Job Summary

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.

Job Description

• 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.

Job Requirements

• 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.

Pay Scale:{$40/hr}on W2
Benefits
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.