Engineer I, Quality

About the company

ICU Medical

Medical devices · 5,001 to 10,000 employees

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.
• 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.
• 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.
• 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% of the time

Key skills

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