Quality Systems Engineer II, Medical Devices

ICU Medical Inc; Salt Lake City (UT); On-site; USD 85,000 - 110,000; Full time

Job summary

ICU Medical Inc. is seeking a Quality Systems professional to ensure servicing of infusion pumps and serialized devices complies with ISO 13485:2016 and 21 CFR Part 820. You’ll support quality operations, investigations, CAPA, risk management, internal audits, and data analysis in a dynamic regulated environment.

The role emphasizes root cause analysis, statistical methods, and cross‑functional collaboration to drive improvements and regulatory readiness across service and field operations.

Qualifications

• 2 years hands-on experience in a regulated industry; medical device experience preferred.
• Strong technical writing and problem solving abilities.
• Excellent written and verbal communication, with ability to summarize to upper management.
• Ability to multi-task in a fast-paced, regulated environment.
• Organize data from multiple sources and write technical reports with executive summaries including statistical analysis.

Responsibilities

• Provide quality oversight to Hub Service/Repair Operations and Field Service Engineering activities.
• Maintain documentation and records per quality procedures.
• Analyze customer complaints for unreturned serialized devices.
• Initiate and complete quality investigations for root cause and CAPA.
• Apply RCCA tools and statistical methods to data collection and reporting.
• Participate in preventive quality and operational improvement projects.
• Support regulatory readiness and regulatory inspection activities on site.
• Assist with Change Requests and quality system updates as needed.
• Lead remediation plans for quality system compliance issues.
• Ensure training compliance and participate in internal audits.
• Support special projects as they arise.

Skills

Quality Systems

Regulated Industry

Root Cause Analysis

FDA/ISO 13485

Technical Writing

Data Analysis

Excel Proficiency

Cross-functional Collaboration

Education

Bachelor’s degree in STEM

2-4 years experience

ASQ CQE / CQA preferred

ISO 13485 Lead Auditor certification a plus

Tools

Excel

Word

PowerPoint

Job description

ICU Medical Inc. is seeking a Quality Systems professional to ensure servicing of infusion pumps and serialized devices complies with ISO 13485:2016 and 21 CFR Part 820. You’ll support quality operations, investigations, CAPA, risk management, internal audits, and data analysis in a dynamic regulated environment.

The role emphasizes root cause analysis, statistical methods, and cross‑functional collaboration to drive improvements and regulatory readiness across service and field operations.