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Description
TITLE: Document Control and Database Administrator
DEPARTMENT: Quality Assurance
REPORTS TO: Director of Quality
EDUCATION/EXPERIENCE:
BA Degree / AA Degree or equivalent. Experienced in Document Control and Database management preferably in the medical device industry.
SUMMARY:
Responsible for creating, maintaining and improving the sites electronic Access databases; development, implementation and maintenance of Quality Management Software; and Document Control activities such as part number and order number assignments, revision control of documents/drawings, processing change orders, data entry and coordination in electronic databases, and paper documentation.
NECESSARY SKILLS:
Experienced in Good Documentation PracticesAdvanced user knowledge of Microsoft Office, Access, Excel, Project, Visio, and WordProficient in Formatting, Drawing, Forms, Frames, Tables, Borders, Numbering, Inserting and Bookmarks.Proficient in creating and modifying macros and advanced formulations between workbooksAdvanced programming in Microsoft AccessExperienced in implementation and maintenance of electronic document control databasesExperienced user of ERP softwareStrong technical writing and oral communication skillsSelf-motivated
ESSENTIAL FUNCTIONS:Support all requirements and/or functions of the Document Control Department
Responsible for all Document Control dutiesResponsible for all electronic databasesReview incoming change requests for accuracy and completenessAssign Part/Document Numbers and Document Change Order (DCO) Numbers; maintain a database of all numbersProcess DCO's, ensure all approval requirements are met, and compile required changes to documents.Make recommendations to management about document control work flow for most efficient implementation of DCOs, including ensuring compliance with ISO and FDA requirements.Maintain all controlled documents in a secure areaEnsure accuracy and integrity of data maintained in the document control databasePrioritize tasks as required to maintain a smooth and timely flow of Document Change OrdersCoordinate interaction between stakeholders to resolve discrepancies and ensure appropriate changes are documented.File and distribute document copies in paper and electronic formatCreate and change department procedures and documentationRequisition supplies and materialsMay be required to assist in other departments and/or perform other duties as assigned
ADDITIONAL NECESSITIES:
Provide a high level of service to internal customers, ensuring that documentation management occurs in a timely and thorough mannerDemonstrate a positive and professional demeanor throughout Quality Assurance and all departmentsUnderstanding of 21 CFR 820, ISO 13485, MHLW Ministerial Ordinance 169 and the IVD Directive
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