Job Description Job Description Document Control Training CoordinatorResponsible for the Management of the EQMS (QCBD). Coordinates the document and change control function as required by applicable medical device regulations. Ensures an effective system exists for identifying, indexing, obsoleting, archiving, and retrieving records required by the quality system. Performs day-to-day functions of the Document Control department. Coordinates the Training function as required by applicable medical device regulations.JOB DUTIES Coordinates changes to controlled documents:Coordinate the activities of Document Control, including the tracking, release, distribution of controlled documents.Issue and process Engineering Change Notice and Approval (ECNs) according to regulatory and company requirementsMaintain revision history through archival of ECNs and prior document revisionsMaintain employee access to current versionsConducts monthly audit of all manufacturing/quality areas to ensure all updated or obsoleted documents are removed.Maintain status of Quality Logs including periodic review of open/pending itemsEnsure notification and timely (three-year) review of procedures through email notification to appropriate personnelMaintains control of Quality Records:Coordinate the archival, storage and destruction of records in accordance with the company's record retention policyCoordinate filing and retrieval of active quality records maintained in the Document Control area. Provides back room audit support during FDA and Corporate inspections.Other duties as requiredTraining Coordinator:Maintain Training curricula for all employeesCoordinate Training notifications for new or modified documentsPerform periodic review of Training Logs and associated monthly reporting. Provides EQMS user training for all levels, including View Only, Reviewer/Approver and PowerUser.Participates in departmental/process improvement projects as required.QUALIFICATIONSDetail oriented, committed to accuracy, efficiency and consistencyStrong organization skills are a mustStrong communication and customer service skillsAbility to multitask efficientlyAbility to be flexible in a fast-paced environmentAbility to work independently with minimal supervisionAbility to apply common sense understanding to carry out instructions furnished in oral or written formAbility to tackle practical job-related problems or recognize the need to ask supervision for assistance.EDUCATION OR TRADE KNOWLEDGE High School Diploma required; Associate degree or higher education preferred3-5 years' relevant work experience.Demonstrated proficiency in Microsoft Word and ExcelFamiliarity with ISO 13485 and cGMP
Not specified in the original listing.
Not specified in the original listing.
