New · posted Oct 15
Merit Medical Systems · Medical Devices
Senior Software QA Engineer I
- South Jordan, UT
- On-site
- Full-time
- Senior & Principal
Open until filled
The role
COMMENTS
Infectious Control Risk Category III:
The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
As an eligible Merit employee, you can expect the following
* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights
* Medical/Dental & Other Insurances (eligible the first of month after 30 days)
* Low Cost Onsite Medical Clinic
* Two (2) Onsite Cafeterias
* Employee Garden | Gardening Classes
* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
* 401K | Health Savings Account
To see more on our culture, go to www.merit.com/careers.
Military Veterans are encouraged to Apply.
Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
What you need
SUMMARY OF MINIMUM QUALIFICATIONS
- 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
PREFERRED QUALIFICATIONSnice to have
- 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
What you'll do
SUMMARY OF DUTIES
Ensures that software used in Merit medical devices, manufacturing systems, and supporting digital platforms meets the highest standards of safety, reliability, and regulatory compliance. Partners closely across departments to ensure that all software—embedded, application-level, cloud, or manufacturing-related—meets design control, risk management, and post-market surveillance expectations.
ESSENTIAL FUNCTIONS PERFORMED
- 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.
Pay and benefits
Merit Medical Systems didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Medical/Dental & other insurances
Low-cost onsite medical clinic
3weeks
3 weeks' vacation, 1 week sick time, paid holidays
401K
Health Savings Account
Onsite cafeterias
Where you'll work
South Jordan, UTOn-siteOpen in Maps (opens in a new tab)
More jobs in South Jordan, UTWorking conditions
DAY (United States of America)
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Reading
• Field of vision/peripheral
From the posting
About Merit Medical Systems
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $103,375 | $122,750 | $137,500 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Merit Medical Systems's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 38 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems9
- GMP and compliance4
- Quality systems and risk4
- Documentation and SOPs3
- Collaboration and leadership3
- Lab testing and methods2
- Validation and qualification2
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
Company hiring pulse
Merit Medical Systems on Regulatory Jobs
- 4
- Open roles
- 4
- Distinct roles
- 2
- Locations
By discipline
- Quality4 100%
By level
- Senior & Principal2 50%
- Associate & Specialist2 50%
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Senior Software QA Engineer I at Merit Medical Systems
Open until filled.