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Engineer I, Quality Job in Dublin, Ohio US

Engineer I, Quality

ICU Medical, Inc. - Dublin, OH

Posted: 12/16/2025 - Expires: 1/15/2026

Job ID: 292999157

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Job Description

Job Description

Position Summary
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.

Essential Duties & Responsibilities


* 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.
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.
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)
* Previous regulated industry experience, preferred.
* Experience in a clean room environment desirable.
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.

* Typically requires travel less than 5

Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjk3MDI3LjEwNTA4QGljdW1lZGNvbXAuYXBsaXRyYWsuY29t

Job Summary

Employment Type:
Full Time Employee
Job type:
Regular Employment
Skill Based Partner:
No
Education Level:
High school graduate
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
N/A
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
Applied Math: 6
Graphic Literacy: 6

Workplace Documentation: 5