Documentation Control Coordinator

Job OverviewUnder general supervision, assists the Directors of Quality and Engineering perform a range of activities to help drive coordinated release of records from the Engineering Change process. This coordination involves ensuring a variety records (e.g., including but not limited to Standard Operating Procedures, Work Instructions, Bills of Materials, Purchasing Specifications and Test Plans) involved with a proposed change are updated, released and trained on by appropriate personnel prior to the change being made effective.Responsibilities and Duties·        Participate in regular Engineering Change Meetings·        Evaluates proposed Engineering Change order and collaborates with the Assigned Engineer to coordinate deliverables from cross functional teams including Quality, Marketing, Engineering and Production·        Review document records to ensure they are complete and meet Regulatory and Quality Management System requirements ·        Uploads documentation to appropriate records within the QMS software for final Review and Approval·        Serves as a resource for training new Assigned Engineers in the process·        Manages the Engineering Change process template and submits revisions as necessary to ensure continuous improvement as matures·        Serves as a SME for Change records during AuditsQualifications·        Bachelor's Degree in Engineering or Life Science ·        3+ years Quality Assurance/Control experience in manufacturing environment.·        Understanding of ISO 13485 implementation·        Proficiency using Microsoft Suite (Word, Excel, PowerPoint)·        Proficiency in using ERP (Netsuite) and Quality (Qualio) enterprise software.·        Proficiency in using SolidWorks engineering software.·        Excellent oral and written communication skills ·        Highly detail-oriented

Created: 2025-02-19