To provide documentation support for the elements of the Device Master Record (Drawing, Bill of Material, Labeling, Routing and Op Codes) and for Venous Access Convenience Kitting documents controlled within the Agile PLM System. General responsibilities may include controlling, creating, revising, approving, designing, obsoleting, and issuing DMR elements and documents related to these items. To provide labeling and graphics direction and support in the design, development and procurement of medical device labeling. Medical Device labeling includes, but is not limited to, product labeling, pre-printed pouches, pre-printed boxes, Directions for Use, and Patient Cards. This position requires very detail-oriented work involving data entry, graphic design work, label printing and various administrative duties. Ensures that labeling meets all medical, legal, and regulatory requirements. Verifies status of label copy and availability concerning packagers, translators, or publishers.
Essential Duties and Responsibilities
Provides support by understanding the business requirements to an extent that requests to change or release DMR elements and controlled documents can be analyzed for internal impact, customer impact, and regulatory impact. Works with the requestor to verify the requestor understands the business impact of their request. Coordinates the review, verification, approval, and processing of requests. Verifies completeness and accuracy before send CO out for approval and implementing the CO.
Responsible to control, issue, distribute (if required), revise, format, inactivate/obsolete, create, and approve DMR elements and documents.
Facilitates the Agile PLM Change Control System - Convenience Kit Workflow, which controls all elements of Venous Access Convenience Kit Device Master Records
Responsible to create, control, revise, format, inactivate/obsolete, approve, and update Agile and Oracle in relation to Drawings, Bill of Materials, Routings, and Labeling for Venous Access Convenience Kit workflow parts.
Bill of materials are created in relation to drawings verifying that components, quantities, deliver to operation sequences, issuing stores accounts, part formats and notes are created correctly.
Responsible to design, control, issue, revise, create, format, obsolete, print, and approve labeling.
Graphics creation for use in multiple systems
OQ testing of label formats prior to release
Package Artwork Design
Label printing, checking and approving
Scanning and Copying
Creating labeling and graphic redlines- electronic and manual
Creating Bill of Material notes redlines regarding labeling
Coordinating Approval Process
Assists with Label Translation requirements
Track progress of Graphics Projects
Assists with distribution projects/outside labeling.
Participates as back up core team member on product and process projects as they relate to graphics and labeling.
Uses the Agile PLM Change Control System to coordinate the approval of labeling.
Assists other members of Documentation as work-loads necessitate
May perform other duties as assigned
Manages in order to ensure compliance with all relevant regulatory/legal requirements
QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES
Individual Contributor - Build Quality into all aspects of their work by maintaining compliance to all quality requirements