Document Control Coordinator

ARCH • Elmhurst, IL

3d

About The Position

The Document Control Coordinator maintains and manages the QCBD (Quality Collaboration By Design) document file system and supports the company’s Quality Management System. The role oversees QCBD-related training, processes document approvals and changes, maintains quality and product records, and provides documentation support to production and other departments. It also supports internal and external audits and may assist with quality-control instruction and other projects as business needs require.

Requirements

• Associate degree in an applicable technical discipline, or equivalent; alternatively, two to three years of experience in the medical device manufacturing industry, document management systems, and/or training, or an equivalent combination of education and experience.
• Basic knowledge of medical regulations.
• Accurate typing skills and extreme attention to detail.
• Knowledge of the ISO 13485 Quality Management System and FDA 21 CFR Part 820 regulations.

Nice To Haves

• Associate degree in an applicable technical discipline is strongly preferred.

Responsibilities

• Maintain, update, and manage the QCBD document file system.
• Organize and oversee QCBD training related to the Quality Management System.
• Execute document approval, release, archival, and obsolescence processes in accordance with the quality system.
• Modify and document changes to Quality System Procedures.
• Provide information to production and other departments when critical quality documentation issues arise.
• Submit and process change orders under ISO 13485 and FDA 21 CFR Part 820.
• Monitor the device history records process for compliance with ISO 13485 and FDA 21 CFR Part 820.
• Review device history records.
• Perform data entry and trend analysis and, when applicable, initiate corrective actions for negative trends.
• Work with management across company areas to resolve document errors and omissions.
• Update and maintain product DMRs.
• Maintain staff training records and work with supervision to ensure QCBD training meets current requirements.
• Accurately enter data into EPICOR.
• Provide document support for internal and external audits as needed.
• May educate and instruct plant personnel on recommended quality-control testing, equipment methods, and acceptable documentation practices.
• Assist other departments with ad-hoc projects and serve as a backup according to business needs.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Education Level: Associate degree