Job Title: Software Quality Engineer Medical Devices
Location: Raleigh, NC - Hybrid, 3 days onsite and 2 days remote
Employment Type: Contract (W2), 12 months
Travel: None
Job Responsibilities
- Own and coordinate software backlogs and product issue management for assigned products.
- Investigate software/product defects to determine root cause, impact, severity, affected users, systems, and software versions.
- Manage issue triage in JIRA, close duplicate issues, and ensure unique issues are thoroughly investigated and documented.
- Assess product risk and safety impact; escalate safety-critical issues for field-action or nonconformance review.
- Collaborate with Systems, Quality, Regulatory, Medical Affairs, Engineering, Sales, Service, and Operations teams.
- Track investigations, corrective actions, and project deliverables to ensure completion within established timelines and budgets.
- Maintain accurate, auditable quality records and clearly communicate investigation findings and resolution status.
Required Qualifications
- Bachelor's degree in Engineering or a related field, or equivalent experience.
- At least 5 years of relevant experience in software quality, product quality, quality engineering, product management, CAPA/issue management, risk management, or regulated-product defect investigation.
- Strong experience with software quality, risk assessment, requirements, and testing.
- Proficiency in JIRA and Microsoft Office.
- Excellent written and verbal communication, critical-thinking, and cross-functional collaboration skills.
- Strong organization, prioritization, ownership, and project coordination abilities.
- Ability to work independently and manage multiple priorities.
- Ability to work onsite in Raleigh three days per week, preferably Tuesday through Thursday.
- Medical device, pharmaceutical, automotive, or other regulated-industry experience preferred.
Pay Scale
Anticipated hourly pay range: $45/hr to $47/hr on W2.
Benefits
Employees hired into this position are eligible for the following benefits, subject to the 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 other than that required by applicable state and local laws.