QA Investigations Specialist: Root Cause & CAPA Expert

Otsuka ICU Medical; Austin (TX); On-site; USD 70,000 - 100,000; Full time

Job summary

Otsuka ICU Medical seeks an Investigations Specialist to review and approve nonconformances, assess impact and lead CAPA actions. You will work with QA, Operations and Regulatory to ensure timely closure of investigations and maintain regulatory compliance.

The role requires strong analytical writing, problem-solving and facilitation skills, with familiarity with FDA regulations and quality systems across global sites.

Qualifications

• Bachelor's degree in a scientific/engineering field.
• 4–6 years in Quality, Manufacturing, Engineering or R&D.
• 2+ years leading investigations for root cause and product impact.
• Experience in regulated/pharmaceutical environments.

Responsibilities

• Review and approve nonconformances and investigation reports.
• Assist in CAPA development and tracking.
• Coordinate investigations with QA, Operations, Regulatory.
• Prepare technical summary reports and data extraction.
• Ensure compliance with FDA and company policies.
• Facilitate timely closure of investigations.

Skills

FDA regulations

Root cause analysis

Investigations systems

Communication skills

Interpersonal skills

Facilitation skills

Technical writing

Word processing

Education

Bachelor's degree

Tools

Word processing

Spreadsheets

Presentation tools

Job description

Otsuka ICU Medical seeks an Investigations Specialist to review and approve nonconformances, assess impact and lead CAPA actions. You will work with QA, Operations and Regulatory to ensure timely closure of investigations and maintain regulatory compliance.

The role requires strong analytical writing, problem-solving and facilitation skills, with familiarity with FDA regulations and quality systems across global sites.