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.

 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.

Job Summary

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