The Global Quality Systems Change Analyst assists in the review, release, and implementation of global quality documents via the change order process. The GQS Change Analyst ensures documentation and record keeping processes conform to all applicable internal procedures and external medical device regulatory requirements. The individual will assist in the day-to-day document control activities within the Global Quality Systems documentation team. Essential functions include at a minimum:
• Performs document control functions by initiating change orders to effectively route, track, process, review, distribute, release, and archive documents
• Collaborates with cross-functional teams and Global Process Owners in the timely release of documents via the change order process
• Organizes and ensures accurate and reliable document requests using SharePoint
• Provides a thorough review of document content prior to routing to ensure adherence to internal processes
• Works closely with translation agency to coordinate document translations
• Adheres to internal processes and provides input for process improvement
• Proactively initiates, develops, and maintains effective working relationships with team members