Quality Systems Engineer II — Medical Devices & Compliance

ICU Medical, Inc.; Salt Lake City (UT); On-site; USD 90,000 - 120,000; 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, FDA 21 CFR Part 820, and related standards.

You will support hub service/repair operations, field service, and warehouse activities, maintain QMS records, perform complaint analyses, drive CAPA investigations, and lead risk management, audits, and regulatory readiness to sustain a compliant, efficient service organization.

Qualifications

• 2 years hands-on experience in a regulated medical device environment.
• Strong technical writing and problem solving skills.
• Excellent written and verbal communication skills.
• Ability to multi-task in a fast-paced environment.
• Proficient data extraction and reporting with executive summaries including statistics.
• Knowledge of FDA regulations and ISO 13485 preferred.
• Experience with RCCA/root cause analysis.
• Proficiency in Excel, Word, and PowerPoint.

Responsibilities

• Provide Quality oversight to Hub Service/Repair Operations and Field Service Engineering and Warehouse daily activities.
• Maintain QMS documentation and records per procedures.
• Analyze customer complaints for unreturned serialized devices.
• Process Quality holds and related records.
• Lead Quality Investigations for root cause and CAPA actions.
• Utilize statistics to support data collection, analysis and reporting.
• Participate in preventive quality and operations improvement projects.
• Contribute to Global Service Quality Management Review and monthly Operations Review.
• Support site readiness for external audits and regulatory inspections.
• Help ensure regulatory compliance and drive quality objectives.

Skills

Regulated industry experience

Technical writing

Communication skills

Multitasking in fast-paced environment

Data organization & reporting

Regulatory knowledge

Statistics

Root cause analysis

Education

Bachelor's degree in STEM

ASQ CQE / CQA certification

ISO 13485 Lead Auditor certification

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, FDA 21 CFR Part 820, and related standards.

You will support hub service/repair operations, field service, and warehouse activities, maintain QMS records, perform complaint analyses, drive CAPA investigations, and lead risk management, audits, and regulatory readiness to sustain a compliant, efficient service organization.