Senior Software QA Engineer I
Merit Beauty15 days ago
South Jordan, UT, USASenior
Responsibilities
- Develop and maintain software quality plans aligned with design controls and global regulatory requirements.
- Ensure compliance with 21 CFR 820.30, ISO 13485, internal procedures, FDA software validation, and CSA guidance.
- Lead software risk analysis activities including FMEA, hazard analysis, fault-tree analysis, and CSA risk activities.
- Review and approve protocols, traceability matrices, requirements, and reports for clarity, completeness, and testability.
- Evaluate and qualify software suppliers through audits and risk-based assessments.
- Lead investigations into software-related issues and field events.
- Ensure robust change management, impact analysis, and regression strategies.
- Partner on vulnerability management, secure design, and patching strategies.
- Support trending, field analysis, and risk updates for released software.
Requirements
- Bachelor’s degree in a relevant engineering discipline or equivalent experience.
- At least eight years of experience in software assurance or regulated software development.
- Strong knowledge of IEC 62304, ISO 14971, ISO 13485, 21 CFR Part 820/QMSR, FDA software validation, and CSA guidance.
- Experience with requirements tools such as Jira or Monday.com.
- Ability to interpret architecture, code structure, and test coverage.
- Preferred experience with Class II or Class III medical devices, AI/ML in regulated environments, cybersecurity standards such as UL 2900, and manufacturing software validation.
- Preferred certifications include ASQ CSQE, ISTQB, or Certified Quality Engineer (CQE).
Benefits
- Day, swing/evening, and night shifts are available.
- Medical, dental, and other insurance benefits are eligible beginning the first of the month after 30 days.
- Low-cost onsite medical clinic and two onsite cafeterias.
- Employee garden and gardening classes.
- Three weeks of vacation, one week of sick time, and paid holidays.
- 401(k) and health savings account.
- The role is based in the United States and includes physical activities such as lifting up to 50 pounds, sitting, standing, bending, writing, reading, and visual work.
Categories