Final Release & Quality Documentation Coordinator

ICU Medical; Dublin (OH); On-site; USD 42,000 - 54,000; Full time

Job summary

ICU Medical is seeking a detail-oriented release specialist to manage finished goods release through Oracle following QA review and approval. You will handle nonconforming products via QA holds and maintain DHR and sterilization documentation while generating required quality certificates.

The role requires familiarity with ISO 13485 and FDA requirements, strong communication skills, and the ability to work in a fast-paced environment. Travel is typically under 5% and office-based.

Qualifications

• High School Diploma or equivalent.
• 1–2 years administrative or clerical experience preferred.
• Microsoft Office experience strongly preferred, but not required
• Previous Oracle experience preferred, but not required
• Familiarity with regulatory standards such as ISO 13485 and FDA requirements.

Responsibilities

• Maintain control of non-conforming products through QA hold process.
• Perform final quality review for all production and sterilization documentation prior to product release.
• Release all conforming finished product through Oracle.
• Perform filing of DHR (device history record).
• Generate Sterility and Certificate of Conformance letters.
• Review documentation and release of outsourced sterile product and maintain files.
• Maintain control of non-conforming products through Oracle QA hold.
• Ensure compliance with laws, regulations, standards and company procedures.

Skills

Teamwork

Communication

Multitasking

Data entry

Office environment

Education

High School Diploma

Tools

Oracle

Microsoft Office

DHR documentation

Job description

ICU Medical is seeking a detail-oriented release specialist to manage finished goods release through Oracle following QA review and approval. You will handle nonconforming products via QA holds and maintain DHR and sterilization documentation while generating required quality certificates.

The role requires familiarity with ISO 13485 and FDA requirements, strong communication skills, and the ability to work in a fast-paced environment. Travel is typically under 5% and office-based.