Document Control Coordinator

ARCH • Elmhurst, IL

3d • $26 - $30

About The Position

The Document Control Coordinator maintains and manages the QCBD (Quality Collaboration By Design) document file system and organizes training related to the Quality Management System. The role handles document approvals, releases, archival, and obsolescence in accordance with the quality system; documents changes to Quality System Procedures; processes change orders under ISO 13485 and FDA 21 CFR Part 820; and supports production and other departments with critical quality documentation issues.

The coordinator monitors and reviews device history records, maintains product DMRs and staff training records, and ensures QCBD training reflects current requirements. The position may include data entry, trend analysis, and initiating corrective actions for negative trends. It also includes entering data into EPICOR, supporting internal and external audits, and potentially instructing plant personnel on quality-control testing, equipment methods, and documentation practices. The role assists with ad-hoc projects, provides backup as needed, and performs other duties as assigned.

Requirements

• Associate degree in an applicable technical discipline or equivalent; an associate degree is strongly preferred.
• 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 regulatory knowledge in medical regulations.
• Accurate typing skills and extreme attention to detail.
• Knowledge of the ISO 13485 Quality Management System and FDA 21 CFR 820 Regulations.

Nice To Haves

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

Responsibilities

• Maintains, updates, and manages the QCBD document file system.
• Organizes and oversees QCBD training related to the Quality Management System.
• Executes document approval, release, archival, and obsolescence according to the quality system.
• Modifies and documents changes to Quality System Procedures.
• Provides information to production and other departments when critical quality documentation issues arise.
• Submits and processes change orders under ISO 13485 and FDA 21 CFR Part 820.
• Monitors the device history records process for compliance with ISO 13485 and FDA 21 CFR Part 820.
• Performs device history record reviews.
• May perform data entry and trend analysis and initiate corrective actions for negative trends.
• Works with management across company areas to resolve document errors and omissions.
• Updates and maintains product DMRs.
• Maintains staff training records and works with supervision to ensure QCBD training meets current requirements.
• Accurately enters data into EPICOR.
• Provides document support for internal and external audits as needed.
• May educate and instruct plant personnel in recommended quality-control testing, equipment methods, and acceptable documentation practices.
• Assists other departments with ad-hoc projects and serves as a backup according to business needs.
• Performs other duties as assigned.

What This Job Offers

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