ICU Medical · 1 month ago
Engineer I, Quality
Dublin, OH, United States
Full-time
Onsite
New Grad, Entry LevelICU Medical is a company focused on providing quality oversight in the manufacturing of medical products. The Manufacturing Quality Engineer I is responsible for ensuring compliance with GMP regulations, coaching personnel, and conducting evaluations to maintain product quality.
Health CareMedical Device
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
Qualification
Required
Exceptional interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative
Strong oral/written communications skills and leadership skills
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
Must be at least 18 years of age
Bachelor's degree from an accredited college or university
Ability to adhere to the GMP requirements of the area
Must be able to occasionally move and lift objects of up to 40 lbs. unassisted
Preferred
Previous regulated industry experience
Experience in a clean room environment
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase