Senior Software QA Engineer I
Merit Medical · South Jordan, UT
QualityFull-timeCompany career page
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Role summary
Merit Medical seeks a Senior Software QA Engineer I to ensure software used in medical devices and manufacturing systems meets safety, reliability, and regulatory standards. The role involves developing quality plans, conducting risk analyses, managing supplier qualifications, and supporting post-market surveillance in a day-shift position based in South Jordan, Utah.
What they're looking for
- Bachelor's degree in relevant engineering discipline or equivalent experience
- Minimum eight years in software assurance or regulated software development
- Strong knowledge of IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 820
- FDA software validation and cybersecurity analysis guidance expertise
- Ability to interpret software architecture, code structure, and test coverage
What you'll be doing
- Develop and maintain software quality plans aligned with design controls and regulatory requirements
- Lead software risk analyses including FMEA, hazard analysis, and cybersecurity activities
- Review and approve test protocols, traceability matrices, and compliance reports
- Evaluate and qualify software suppliers through audits and risk-based assessments
- Lead investigations of software-related issues and support field event analysis
Privacy & handoff
This role links to Merit Medical's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.