Senior QA Engineer — Impactful Medical Devices

Merit-Medical-Systems-Inc.; South Jordan (UT); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/dental insurance

401(k)

Onsite clinic

Paid holidays

3 weeks vacation

Job summary

Merit Medical is seeking a Quality Engineer to perform both routine and advanced quality engineering tasks for specific product lines. The role involves risk analysis, validation/verification support, and driving quality improvements across processes and documentation.

You will mentor team members, review ECNs, and participate in supplier audits while ensuring compliance with 21 CFR 820 and ISO standards. This position requires collaboration across cross-functional teams in a manufacturing

Qualifications

• Bachelor's degree in Engineering or related field; six years of quality engineering experience.
• Strong interpersonal and communication skills; ability to work in a team.
• Solid knowledge of 21 CFR 820, ISO 13485, ISO 14791, and other medical device standards.
• Experience with statistical methodologies and quality tools (lean, Six Sigma).
• Familiarity with regulatory requirements and quality system improvements.
• Experience with quality audits, CAPAs, deviations, and supplier quality activities.

Responsibilities

• Perform routine and complex quality engineering for product lines under supervision.
• Lead risk management activities and update risk analyses.
• Review and approve ECNs for validation, verification, and inspection methods.
• Mentor engineers and technicians; supervise as needed.
• Perform supplier quality audits and monitor supplier performance.
• Investigate nonconformances and drive corrective and preventive actions.
• Ensure quality system effectiveness through data analysis and process improvements.
• Support internal and supplier audits and maintain documentation.

Skills

Quality engineering

Data analysis

Team collaboration

Written and verbal communication

Education

Bachelor's degree in Engineering or related field

Tools

MasterControl

SmartCAPA

Oracle

Crystal

Excel

Job description

Merit Medical is seeking a Quality Engineer to perform both routine and advanced quality engineering tasks for specific product lines. The role involves risk analysis, validation/verification support, and driving quality improvements across processes and documentation.

You will mentor team members, review ECNs, and participate in supplier audits while ensuring compliance with 21 CFR 820 and ISO standards. This position requires collaboration across cross-functional teams in a manufacturing