Job DescriptionPosition 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)
- 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% of the time
About UsICU 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. Our focus allows us to bring you:
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement: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 We are committed to providing equal access and opportunities for all candidates.
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