Quality Document Systems Management Specialist I

Becton Dickinson seeks a Quality Document Systems Management Specialist I to serve as a subject matter expert in document control and change management processes. The role involves managing change requests, maintaining controlled documents, and supporting continuous improvement in an FDA-regulated medical device environment.

Responsibilities

• Serve as subject matter expert providing guidance and training on document control and change management processes
• Lead and execute assigned team projects with minimal supervisory oversight
• Manage end-to-end change request lifecycle including creation, review, and documentation within EDMS
• Develop and analyze workload and performance metrics; present findings to leadership
• Participate in regulatory audits, inspections, and quality system activities as required

Requirements

• Associate's or bachelor's degree in related field or equivalent experience
• Minimum 1 year documentation experience in FDA/GMP-regulated environment
• 2–4 years relevant quality or documentation experience
• Advanced proficiency in English reading, writing, and communication
• Intermediate to advanced Microsoft Office skills (Outlook, Word, Excel, PowerPoint)
• Experience with electronic document management systems (MasterControl, PEGA, or similar)
• Intermediate knowledge of quality management system documentation and regulatory standards