Document Control Specialist

Essential Functions

• Issues Quality System documents and coordinate the training process
• Issues device master record documents (manufacturing process specifications, inspection plans, routers, etc.) and other technical documents during the development, release, and maintenance phases of product realization
• Processes Document Change Orders (DCOs) to implement all controlled documentation and maintain the distribution of controlled copy documents
• Organizes and communicates status of work to management and other personnel as required and keeps them informed of objectives and progress
• Ensures documentation is complete, properly formatted and meets corporate standards
• Affords assistance in assigning and tracking new part numbers through the development cycle
• Performs database searches, data analysis, and reporting to assist design engineers on product development
• Utilizes multiple manufacturing business systems, spreadsheets, graphs, word processors and product information management systems in order to facilitate document release, change, and data storage & retrieval processes
• Affords assistance in conducting various training classes relating to documentation practices that pertain to Quality on an as-needed basis
• Oversees new item creations as well as set up within the system
• Creates and updates all BOMs and Routes
• Maintains oversight of all transactions within AX
• Troubleshoots and fixes any and all AX issues that arise, including improvements and functional testing
• Updates and maintains Net Dimensions training system
• Participates in continuous improvement activities and implements changes for improvement
• Keeps supervisor informed of work-related activities and issues related to agreed-upon goals and objectives

Qualifications

• High school diploma or higher with minimum of 2 years progressive work experience, preferably in the medical device industry or other regulated industry
• Ability to review documentation for accuracy, perform data entry, scan and file documents
• Knowledgeable with Microsoft Word and Excel programs
• Experience utilizing planning software
• Experience with training, developing and reviewing of planning software processes and procedures from a functional perspective
• Good organizational, typing, analytical, and critical thinking skills
• Good communication and writing skills