Engineer , Quality

Engineer I, Quality

ICU Medical

Location: Delaware, OH

Salary: $67,000.00‑$72,000.00

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 elevate 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.

• Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are being followed in accordance with GMP compliance.
• Conduct real‑time batch record reviews in assigned areas.
• Review equipment logbooks and evaluate 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 and provide corrective actions as necessary.
• Monitors assigned area(s) for compliance to procedures and cGMPs specific to equipment, documentation, and personnel.
• Perform 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.
• Provide similar quality oversight functions for satellite locations as assigned or required.

• Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.
• Strong oral and written communication skills and leadership skills required.
• Ability to work well with all levels of personnel throughout the facility.
• Capable of rapidly absorbing technical data and applying this knowledge to a pharmaceutical manufacturing environment.

• 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 is preferred.
• Experience in a clean room environment is desirable.

The MQ Quality Engineer role receives general direction daily from the MQ supervisor and receives direction from MQ management as needed. The position requires performance of duties in a manufacturing and office environment.

In the manufacturing environment:

• Work is performed in a clean room environment and must adhere to GMP requirements of the area.
• High noise areas, radiological hazards or lasers may be encountered, and/or biological hazards may be present.
• Must occasionally move and lift objects up to 40 lbs unassisted.

In the office environment:

• This job operates in a professional office environment and routinely uses standard office equipment.

Typical travel less than 5% of the time.

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically‑essential IV therapy and high‑value critical care products for hospital, alternate site, and home care settings. We’re ready to bring you consistent quality, innovation, and value in more areas than ever.

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at

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• Entry level

• Full‑time

• Quality Assurance

• Medical Equipment Manufacturing

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