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About the Role
The Manufacturing Quality Engineer I (QE) provides oversight and guidance in manufacturing operations, ensuring GMP compliance. The QE coaches manufacturing personnel on GMP and procedural compliance, empowering them to identify and escalate quality issues to ensure product quality. QEs perform safety inspections, identify and correct GMP issues, and recommend corrective actions to management.
Responsibilities
- Conduct evaluations and compliance walkthroughs of manufacturing and warehouse personnel and areas to ensure procedures are followed in accordance with GMP compliance.
- Conduct real-time batch record reviews in assigned areas.
- Review equipment logbooks and evaluate adjustments for impact to product quality.
- Create, review, and revise procedures and assist with CAPA investigations.
- 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 manufacturing areas regarding manufacturing events and deviations.
- Provide corrective actions as necessary.
- Monitor assigned area(s) for compliance to procedures and cGMPs specific to equipment, documentation, and personnel.
- Perform quality review and approval of change control documentation related to preventive maintenance and calibration.
- 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.
- Provide similar quality oversight functions for satellite locations as assigned or required.
Requirements
- 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.
- Work is performed in a clean room environment, requiring adherence to GMP requirements.
- Ability to work in high noise areas, areas with radiological hazards or lasers, and/or areas where biological hazards may be encountered.
- Able to occasionally move and lift objects of up to 40 lbs. unassisted.
Skills
- Teamwork
- Adaptability
- Innovation
- Initiative
- Oral communication
- Written communication
- Leadership
- Technical data absorption
- Application of technical knowledge
Location
- Onsite
Work Type
- Full-time
- 3rd shift
- Wednesday - Friday every other Saturday (6:00pm - 6:00am)
Experience Level
- 0-2 years of experience
Education Level
- Bachelor’s degree in Engineering or related field (STEM) from an accredited college or university
About the Company
- 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.
Equal Opportunity
- 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 austinhr@icumed.com.
- We are committed to providing equal access and opportunities for all candidates.