Spec 2 – Quality Document Sys Mgmt

Bachelor’s degree in Computer Science, Information Technology, or a related field (or equivalent work experience)
Experience in Document Control/Configuration Management
Experience with medical devices in a regulated environment (i.e. QSR, GMPs, ISO 13485, ISO 9001)
Experience using SAP a plus
Experience using TeamCenter DMS a plus
In-depth understanding and working knowledge with Microsoft Office applications and other standard business applications (Word, Excel, Outlook, Adobe, etc.)
Exhibits attention to detail as well as strong decision making and problem-solving skills

Demonstrates knowledge of theories, practices and processes associated with quality document or configuration management systems
Demonstrates in-depth skills generating, processing and managing controlled documentation
Provides guidance and coaching to professional associates using the change order process
Assists with the development, deployment and maintenance of controlled documentation and supporting systems
Works with change order owners to collaborate on, research, analyze, and verify change orders submitted to Document Control. Verifies completeness of same
Assist with special projects in support of Quality objectives
Experienced using electronic documentation management systems
Able to prioritize and implement tasks in a fast-paced environment
Possesses exceptional communication skills, including written, verbal, and presentation skills
Implements and completes additional tasks and responsibilities assigned by reporting manager
Able to work independently with minimal guidance
Able to determine own work priority
Acts as a resource for colleagues with less experience

Experience with Material Master, Part Number Generation, Bill of Materials, Inspection Plans are a plus