Document Control Coordinator

Principal Duties and Responsibilities

• Creation of Device Master Records such as routers, master cross references, and bill of materials within the ERP system.
• Maintain Device Master Records and Device History Records as well as other quality system documents such as training records, monitoring records, authorized signature lists, etc.
• Assist with new part number assignment process by creating new part numbers within ERP system for design teams and Marketing department.
• Assist with leading weekly change control meetings and processing of all change orders within the quality system.
• Handle distribution of all change orders (engineering, specification, and labeling) to appropriate departments.
• Assist with the maintenance of the company intranet, Livelink/SAP web based software to ensure the most current document revisions are available at all points of use.
• Assist with processing Instructions for Use and all labeling intended for domestic and international distribution. This includes approval of product labeling using the label producer software.
• Maintenance of various databases to ensure compliance to regulations such as indices used for procedures, drawings etc.
• Assist with preparing and organizing documents for offsite storage archival and/or archival onto CD. Maintain storage logs.
• Process and distribute various document requests to departments as needed.
• Complete various projects as assigned by the supervisor in addition to general filing and copying.

Qualifications & Requirements

High School education or equivalent plus one to two years previous regulatory/quality or related experience and six months on-the-job training, or an equivalent combination of education and experience.

Additional Information: Job Summary

Under minimal supervision, maintains Device Master Record and Device History Records as part of the quality system, and maintains department databases.