Quality Engineer I

Otsuka ICU Medical; Austin (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

Otsuka ICU Medical is seeking a Manufacturing Quality Engineer I to oversee GMP compliance in our Austin-based operations. The role involves coaching manufacturing personnel on GMP and procedural compliance while identifying quality issues and driving CAPA and process improvements.

This position supports safety inspections, change control reviews, and collaborative quality decisions across manufacturing areas, including satellite locations, with a focus on ensuring a quality product and reliable

Qualifications

• Bachelor's degree in Engineering or related field from an accredited college or university.
• 0-2 years of experience required.
• Previous pharma experience preferred.
• Experience in a clean room environment desirable.

Responsibilities

• Conduct evaluations and compliance walkthroughs for GMP.
• Real-time batch record reviews in assigned areas.
• Review equipment logbooks and assess impact on product quality.
• Create, review and revise procedures and assist CAPA investigations.
• Perform data analysis to identify corrective actions and process improvements.
• Support quality input for manufacturing events and deviations.
• Perform safety inspections and address hazards.

Skills

Interpersonal skills

Communication skills

Leadership

Adaptability

Teamwork

Education

Bachelor's degree in Engineering or related field

Job description

Position Summary

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. 3rd shift - Wednesday - Friday every other Saturday (6:00pm - 6:00am)

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

• Bachelor's degree in Engineering or related field (STEM) from an accredited college or university is required
• 0-2 years of experience required
• Previous pharma experience, preferred.
• Experience in a clean room environment desirable.

Minimum Qualifications

• Must be at least 18 years of age

Travel Requirements

Typically requires travel less than 5% of the time

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.

About Us

Innovation, Impact, and Purpose. Find Your Future Here. We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption. When you work here, you become part of something bigger-a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide. We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters. Join us and help shape the future of IV solutions.

EEO Statement

Otsuka 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 [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

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Otsuka ICU Medical CCPA Notice to Job Applicants