Senior Software QA Engineer – Regulated Medical Devices

Merit Medical Systems, Inc.; South Jordan (UT); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical/Dental & Other Insurances

Onsite Clinic

Onsite Cafeterias

Vacation & Holidays

Job summary

Merit Medical Systems, Inc. seeks a qualified Software Assurance professional to ensure software across devices, manufacturing systems, and digital platforms adheres to design controls and regulatory standards. You will collaborate across functions to manage risk, validation, and post-market surveillance.

Role requires deep knowledge of IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 820. Experience with Jira and Monday.com is preferred. Day shift in the United States; on-site work in Utah.

Qualifications

• Bachelor's degree in a relevant engineering field or equivalent.
• 8+ years of experience in software assurance or regulated software development.
• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 820 / QMSR.

Responsibilities

• 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.

Skills

IEC 62304

ISO 14971

ISO 13485

21 CFR Part 820 / QMSR

Regulatory compliance

Software assurance

Education

Bachelor's degree in relevant engineering discipline

Tools

Jira

Monday.com

Job description

Merit Medical Systems, Inc. seeks a qualified Software Assurance professional to ensure software across devices, manufacturing systems, and digital platforms adheres to design controls and regulatory standards. You will collaborate across functions to manage risk, validation, and post-market surveillance.

Role requires deep knowledge of IEC 62304, ISO 14971, ISO 13485, and 21 CFR Part 820. Experience with Jira and Monday.com is preferred. Day shift in the United States; on-site work in Utah.