Document Control Coordinator

ARCH • Elmhurst, IL

1d • Onsite

About The Position

The Document Control Coordinator is responsible for maintaining and managing the Quality Collaboration By Design (QCBD) document file system, overseeing QCBD training related to the Quality Management system, and executing document approval, release, archival, and obsolescence processes according to the quality system. This role involves modifying and documenting changes to Quality System Procedures, serving as a key information source for production and other departments regarding critical quality documentation, and processing change orders in compliance with ISO 13485 and FDA 21 CFR Part 820. The coordinator will monitor the device history records process, perform device history record reviews, and may engage in data entry, trend analysis, and initiating corrective actions for negative trends. Additionally, this position collaborates with management to resolve document errors, updates product Device Master Records (DMRs), maintains staff training records, and ensures all QCBD training meets current requirements. Accurate data entry into EPICOR, providing document support for audits, and potentially educating plant personnel on quality control practices are also key functions. The role includes assisting other departments with ad-hoc projects and serving as a backup as needed.

Requirements

• Associate degree in applicable technical discipline is strongly preferred or equivalent, or two (2) to three (3) years of experience in medical device manufacturing industry and/or document management systems and/or training, or equivalent combination of education and experience.
• Basic regulatory knowledge in medical regulations.
• Accuracy of typing skills and extreme attention to detail are required.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.

Responsibilities

• Maintains, updates and manages QCBD (Quality Collaboration By Design) document file system.
• Organizes and oversees QCBD training related to the Quality Management system.
• Executes document approval, release, archival, and obsolescence, per the quality system.
• Modifies and documents changes to Quality System Procedures.
• Functions as an information source for 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 device history records process to meet ISO 13485 and FDA 21 CFR Part 820.
• Performs device history record review.
• May perform data entry and trend analysis and initiate negative trend corrective actions.
• Works with management in all company areas to effectively resolve document errors/omissions.
• Updates and maintains product DMR’s.
• Maintains staff training records and working with supervision ensuring that all QCBD training is to 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 and equipment methods and acceptable documentation practices.
• Assists other departments with ad-hoc projects and serves as a back up per business needs.
• Other duties as assigned.

What This Job Offers

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