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    Quality Engineer I - Austin, United States - ICU Medical

    ICU Medical
    ICU Medical Austin, United States

    4 weeks ago

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    Description

    FLSA Status:

    ExemptShift: Wed-Fri and every other Sat from 6p-6aPosition SummaryThe 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)
    • 0-2 years of experience required
    • Previous pharma 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% of the timeICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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