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New · posted Oct 15

ICU Medical · Medical Devices

Engineer II, Quality

  • Salt Lake City, UT
  • On-site
  • Full-time
  • Associate & Specialist
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PayNot published
EmploymentFull-time
LocationSalt Lake City, UTOn-site
LevelAssociate & Specialist
FunctionQuality AssuranceQuality
Deadline

Open until filled

The role

Works in a Quality Systems environment to ensure that the servicing of infusion pumps and other serialized medical devices meets the requirements of ISO 13485:2016, 21 CFR Part 820, and other applicable regulations and standards.

This position also supports key areas to maintain an effective Quality System, such as: quality operations, complaint investigations, CAPA investigation, risk management, internal audit, and service data collection, analysis, and trending. The incumbent must be a quality professional that can work and develop within a quality management system and has sufficient skills, experience and competencies to perform in a very dynamic role within a regulated environment.

What you need

  • Must be at least 18 years of age
  • Bachelor’s degree from an accredited college or university (STEM discipline)
  • 2-4 years experience
  • ASQ CQE / CQA certification is preferred
  • ISO 13485 Lead Auditor certification a plus

Knowledge, Skills & Qualifications

  • 2 years hands-on experience working in a regulated industry; medical device experience preferred
  • Superior technical writing and problem solving skills
  • Superior written and verbal communication skills, capable of synthesizing a problem statement, situation, or observation and providing a concise synopsis to upper management
  • Ability to work and multi-task in a fast-paced environment
  • Must be capable of organizing data from multiple sources, extracting key information, and writing technical reports with executive summaries including statistical analysis of data
  • Combined education plus work experience in a medical device industry will effectively align incumbent with his/her ability to contribute to the organization
  • Demonstrated knowledge of medical device regulations and experience with FDA regulatory standards and ISO 13485 strongly preferred
  • Working knowledge of basic statistical techniques
  • Advanced knowledge and experience in root cause analysis (RCCA) and problem-solving techniques
  • Intermediate working knowledge of Excel (pivot table, filtering, graphing), Word, and PowerPoint

Physical Requirements and Work Environment

  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.
  • Typically requires travel less than 5% of the time

Skills named in this posting

What you'll do

  1. Support and provide Quality oversight to the Hub Service/Repair Operations and/or Field Service Engineering organizations and Warehouse team in their daily activities.
  2. Maintain documentation and records resulting from quality management system activities according to established procedures.
  3. Perform customer complaint analyses for unreturned serialized devices.
  4. Process Quality holds.
  5. Initiate and complete Quality Investigations to identify root cause and implement effective solutions (corrective and preventive actions) for product/process quality issues, corporate/external audit observations, and quality system compliance issues as required.
  6. Utilize technical background (including statistical knowledge and root cause analysis tools) to assist in data collection, analysis, and reporting. This activity may relate to process improvement efforts as well as serve as an input to management for decision making.
  7. Actively participates in preventive/proactive quality and operations improvement projects.
  8. Provide inputs to the Global Service Quality Management Review and monthly Operational Review meetings.
  9. Support Quality Management on site readiness activities associated with external audits and regulatory inspections (can be asked to present and defend in the front room regarding complaint analysis and other Service QMS topics).
  10. Contribute to oversight of site regulatory compliance, including follow-up to regulatory commitments.
  11. Oversee and drive improvements to meet established quality objectives and performance indicator goals associated with tasks under responsibility.
  12. May support validation processes and risk assessments as required.
  13. Provide support to initiate and process Change Request packages for Quality System procedure changes.
  14. May lead or coordinate remediation plans associated with Quality System compliance issues.
  15. Ensure fulfillment of compliance training requirements per established schedule.
  16. May conduct internal audits per established internal audit schedule and as designated by Quality Management.
  17. Perform other related duties as assigned or required.
  18. Work on special projects as they arise.

Where you'll work

Salt Lake City, UTOn-siteOpen in Maps (opens in a new tab)

More jobs in Salt Lake City, UT

Job intelligence

The context around this role

Live data · October 15, 2026

Salary intelligence

How the pay compares

Associate & Specialist roles in the US157 roles publishing pay

Middle half $59,000 to $94,000, median $78,500
Annual base pay
Annual base payLowMedianHigh
All US$59,000$78,500$94,000

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 ICU Medical's own promotion track.

  1. This role

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $79K median227 open

  2. Next step

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $123K median353 open

  3. Later

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $153K median136 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Clinical Quality Assurance

    $209K median114 open

  5. Later

    VP & Executive

    Often: Vice President, Quality Assurance · AVP

    $302K median15 open

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.

GMP and compliance: 10 linesDocumentation and SOPs: 3 linesInvestigations and CAPA: 6 linesValidation and qualification: 1 lineQuality systems and risk: 12 linesData and digital systems: 2 linesCollaboration and leadership: 6 linesGMPDocumentationInvestigationsValidationQuality systemsData systemsTeamwork
  • Quality systems and risk12
  • GMP and compliance10
  • Investigations and CAPA6
  • Collaboration and leadership6
  • Documentation and SOPs3
  • Data and digital systems2
  • Validation and qualification1

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.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

ICU Medical on Regulatory Jobs

7
Open roles
7
Distinct roles
4
Locations

By discipline

  • Quality6 86%
  • Regulatory1 14%

By level

  • Associate & Specialist4 57%
  • Senior & Principal3 43%
See all 7 ICU Medical roles

More roles at ICU Medical

All 7 ICU Medical roles

Similar Quality Assurance roles elsewhere

Engineer II, Quality at ICU Medical

Open until filled.

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    Engineer II, Quality at ICU Medical — Salt Lake City, UT | Regulatory Jobs