Document Control Coordinator

Role Overview The position involves managing and updating the QCBD (Quality Collaboration By Design) document system, overseeing training related to the Quality Management System, and ensuring document approval, release, and archival in compliance with quality standards. Key Responsibilities Modify and document changes to Quality System Procedures. Serve as a resource for production and departments on quality documentation issues. Process change orders under ISO 13485 and FDA 21 CFR Part 820. Review device history records, perform data entry, trend analysis, and initiate corrective actions. Maintain product DMRs and staff training records, ensuring current training requirements are met. Support internal and external audits with documentation. Assist departments with ad-hoc projects and provide training on quality control practices. Qualifications & Skills Associate degree in a technical field or 2-3 years industry experience; equivalent education/experience acceptable. Basic knowledge of medical regulations, ISO 13485, and FDA 21 CFR 820. Strong attention to detail, accurate typing skills, and data management proficiency. #J-18808-Ljbffr Tharp Consulting