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# Senior Software QA Engineer I

- **Company:** Merit Medical Systems, Inc.
- **Location:** South Jordan, UT, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Testing (Software), Artificial Intelligence, Asana, JIRA, Code Coverage, Software Quality, Failure Mode Effects Analysis, Software Engineering, Verification and Validation (Software), Software Vulnerability Management, Code Structure, Industrial Software
- **Published:** August 26, 2026
- **Apply:** https://diversityjobs.com/main/sendform/8/8/28176/1/18078864?backUrl=%2Fcareer%2F18078864%2FSenior-Software-Qa-Engineer-I-Utah-South-Jordan

## About the Role

* Education and/or experience equivalent to a Bachelor's degree in relevant engineering discipline.
 * A minimum of eight (8) 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 (e.g., Jira, Monday.com)
 * Ability to interpret architecture, code structure, and test coverage, * Experience in Class II or Class III medical devices.
 * Experience with AI/ML in regulated environments.
 * Experience with cyber-security standards (e.g., UL 2900).
 * Certifications such as ASQ CSQE, ISTQB, Certified Quality Engineer (CQE)
 * Experience in independently performing Advanced Operations or manufacturing software validation.

COMPETENCIES

 * Interpersonal skills

 * Organization

 * Written and Verbal Communication

 * Problem Solving

## Description

* Develops and maintains software quality plans aligned with design controls and global regulatory requirements.
 * Ensures compliance with 21 CFR 820.30, ISO 13485, and internal procedures.
 * Leads software risk analysis (FMEA, hazard analysis, fault-tree analysis) and CSA risk activities
 * Reviews and approves protocols, traceability matrices, and reports; requirements for clarity, completeness, and testability.
 * Evaluates and qualifies software suppliers (audits, risk-based assessments).
 * Leads investigations for software-related issues and field events.
 * Ensures robust change management, impact analysis, and regression strategies.
 * Partners on vulnerability management, secure design, and patching strategies.
 * Supports trending, field analysis, and risk updates for released software.
 * Performs other duties, as assigned.


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