Quality Documentation & Compliance Specialist

RXinsider LTD.; Dublin, Northern (OH, KY); Hybrid; USD 38,000 - 52,000; Full time

Job summary

ICU Medical is seeking an administrative specialist to support the release of finished goods. You will manage QA holds, review production documentation, and release conforming products through Oracle, while maintaining DHR and sterilization records.

Knowledge of ISO13485 and FDA requirements is a plus. This role requires 1-2 years of clerical experience, strong communication skills, and the ability to work in a fast-paced environment.

Qualifications

• 1-2 years administrative or clerical experience preferred.
• Microsoft Office experience preferred, but not required.
• Familiarity with regulatory standards such as ISO 13485 and FDA requirements is a plus.

Responsibilities

• Release finished goods through Oracle after review and approval of documents.
• Maintain QA hold process for nonconforming products.
• Perform final quality review of production and sterilization documentation prior to release.
• Generate Sterility and Certificate of Conformance letters.
• Maintain DHR and outsourced sterilization documentation and files.
• Ensure compliance with applicable laws, regulations, standards and company procedures.

Skills

Administrative experience

Microsoft Office

Data entry

Communication skills

Teamwork

Regulatory knowledge

Education

High School diploma

Tools

Oracle

Job description

ICU Medical is seeking an administrative specialist to support the release of finished goods. You will manage QA holds, review production documentation, and release conforming products through Oracle, while maintaining DHR and sterilization records.

Knowledge of ISO13485 and FDA requirements is a plus. This role requires 1-2 years of clerical experience, strong communication skills, and the ability to work in a fast-paced environment.