Quality Engineer I: GMP Compliance & CAPA (3rd Shift)

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

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