Quality Investigations & CAPA Specialist

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 85,000 - 105,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX is seeking an Investigations Specialist to review nonconformances, assess impact, determine root cause, and help implement CAPAs to prevent recurrence.

You will collaborate with Quality, Operations, and Regulatory teams, maintain records, and ensure compliance with FDA and global regulations while supporting timely investigation closure. Requires 4–6 years of experience, a bachelor's degree, and strong writing and communication skills.

Qualifications

• Bachelor's Degree is required: BS, Technical (Chemistry, Biology, Microbiology, or Engineering preferred).
• 4–6 years' experience in Quality, Manufacturing, Engineering or R&D functions or any combination.
• Prior investigation writing experience with a minimum of 2 years leading investigations determining root cause and product impact.
• Experience in a regulated industry; Pharmaceutical preferred.

Responsibilities

• Assist with the development of investigational plans for new events and coordinate with investigators to determine root cause and CAPAs.
• Facilitate investigation teams and liaise between Quality, Operations, and Regulatory/Compliance for timely closure.
• Perform quality reviews of nonconformances and investigation reports with documented evidence.
• Review and approve Quality system records (nonconformances, investigations, CAPAs, etc.).
• Organize data, extract key information, and write technical summaries.
• Ensure compliance with FDA and global regulatory agencies and company policies.
• Perform other related duties as assigned or required.

Skills

FDA regulations

Quality tools

Oral & written communication

Interpersonal skills

Facilitation

Technical writing

MS Office

Education

Bachelor's degree in Chemistry, Biology, Microbiology, or Engineering

Tools

Investigations systems

Root cause analysis tools

Microsoft Word/Excel/PowerPoint

Job description

Otsuka ICU Medical LLC in Austin, TX is seeking an Investigations Specialist to review nonconformances, assess impact, determine root cause, and help implement CAPAs to prevent recurrence.

You will collaborate with Quality, Operations, and Regulatory teams, maintain records, and ensure compliance with FDA and global regulations while supporting timely investigation closure. Requires 4–6 years of experience, a bachelor's degree, and strong writing and communication skills.