Senior Software QA Engineer I
Merit Medical
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 4 days ago
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