Document Control Specialist
CurrentGauthier Biomedical is a manufacturer of high-quality instruments for the medical device industry. As a Document Control Specialist, I am responsible for accurately maintaining the documentation in the department. Current responsibilities:• Verify and process Device History Record (DHR) folders and ensuring quality in certifications for shipments for the company.• Managing preventative maintenance calendars for all plant machines and equipment using spreadsheet tracking.• Finalizing customer complaints, ensuring proper closure, status updates, and organization of digital and hard copy files.• Complete calibration certificate processes with scanning, network organization and hard copy filing.• Overseeing the shredding services for secure disposal of old DHR hard copy files.Selected accomplishments include:• Accurately maintains a comprehensive filing system and computer database for all documentation to be retained as required in the document control center.• Successfully cleared a 2-year backlog of Device History Record (DHR) Final Instrument in six months.• Verified and thoroughly processed 3,724 DHR folders and ensuring quality in certifications for 861 shipments in the first year.• Developed and implemented standard operating procedures to streamline undefined responsibilities, enhancing department efficiency.• Effectively managed critical information and ensured business continuity during a two-week network outage caused by a security breach. Successfully located, organized, and distributed hard copy documents, maintaining workflow without digital access.• Trained new hires on Document Control duties.ISO certified.