New · posted Oct 15
ICU Medical · Medical Devices
Engineer I, Quality
- Dublin, OH
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
The Manufacturing Quality, Quality Engineer I (QE) is responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of GMP compliance. The QE will coach manufacturing personnel, on proper GMP and procedural compliance and empower them to identify and escalate quality issues, to ensure a quality product. The QEs are responsible for performing Safety Inspections on a scheduled frequency; they will identify and correct GMP issues while being expected to provide recommendations to management on corrective actions.
This role is 100% onsite at our Dublin, OH manufacturing facility.
What you need
Minimum Qualifications, Education and Experience
- Must be at least 18 years of age
- Bachelor’s degree from an accredited college or university is required, preferably in Engineering or the sciences (Biology/Chemistry/Microbiology/Pharmacy)
- 0-2 years of experience
- Previous regulated industry experience, preferred.
- Experience in a clean room environment desirable.
Knowledge, Skills & Qualifications
- Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.
- Strong oral/written communications skills and leadership skills required.
- Ability to work well with all levels of personnel throughout the facility.
- Capable of rapidly absorbing technical data and the ability to apply this knowledge to a pharmaceutical manufacturing environment.
Physical Requirements and Work Environment
- The MQ Quality Engineer role receives general direction daily from MQ supervisor and receives direction from MQ management as needed. The position requires both performance of duties in a manufacturing and office environment.
- While working in the manufacturing environment:
- Work is performed in a clean room environment. This requires the ability to adhere to the GMP requirements of the area.
- There are high noise areas, areas where radiological hazards or lasers may be encountered and/or areas where biological hazards may be encountered.
- Must be able to occasionally move and lift objects of up to 40 lbs. unassisted
- While working in the office:
- This job operates in a professional office environment and routinely uses standard office equipment.
- While working in the manufacturing environment:
- Typically requires travel less than 5% of the time
What you'll do
- Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance.
- Conducts real time batch record reviews in assigned areas.
- Reviews equipment logbooks and evaluates adjustments for impact to product quality.
- Create, review, and revise procedures and assist with CAPA investigations as applicable.
- Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.
- Provide input and decision making for quality in the manufacturing areas with regard to manufacturing events and deviations. Provide corrective actions as necessary.
- Monitors assigned area(s) for compliance to procedures and cGMPs specific to equipment, documentation, and personnel.
- Performs quality review and approval of change control documentation related to preventive maintenance and calibration as assigned.
- Conduct Safety Inspections and take prompt action to eliminate work hazards.
- Initiate product and commodity restrictions in accordance with local procedures.
- Perform other related duties as assigned or required.
- Also provide similar quality oversight functions for satellite locations as assigned or required.
Where you'll work
Dublin, OHOn-siteOpen in Maps (opens in a new tab)
More jobs in Dublin, OHJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in Ohio6 roles publishing pay
Associate & Specialist roles in the US157 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Ohio (middle half) | $53,000 | $66,250 | $79,500 |
| All US (middle half) | $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.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs7
- GMP and compliance5
- Collaboration and leadership3
- Investigations and CAPA2
- Quality systems and risk2
- Lab testing and methods1
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.
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%
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Engineer I, Quality at ICU Medical
Open until filled.