Job DescriptionPrimary Function of Position:
The Document Control Specialist 3 is responsible for assisting the Document Control lead and manager in maintaining and continuously improving the Document Control Quality System in order to support the business and release of marketed products, meet regulations and established requirements. Ensures that product and product related documents are processed through the Agile database in compliance with established procedures, Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), Deviations and Engineering Change Requests (ECRs). This role requires sedentary and repetitive working conditions.
Roles & Responsibilities: Process documentation changes in Agile: Ensure electronic capture and retrieval of quality documents and records by reviewing, evaluating and processing changes accurately and in a timely manner while ensuring that they meet the department goals and objectivesAudit changes for accuracy and completion. Review changes to ensure that language used in the change is adequate and in compliance. Ensure that changes are in a closed loop and all discrepancies (if any) are addressed and closed before the change is releasedProvide clear and accurate communication to internal customers. Clearly communicate both verbally and in writing, with Originators when discrepancies are found. Give precise guidance to originators for the proper process to follow when to correct issues/discrepancies.Provide Agile and change procedure training support as needed to co-workers within and outside Document ControlPromptly respond to questions and issues raised by Originators and ApproversWork with ECO Coordinator to select changes for CCB meetings based on production impactRepresent Document Control at CCB meetingsWork with ECO Coordinator and Originators in following-up, analyzing and helping to resolve open ECO/MCO issuesProvide continuous improvement of Document Control processes/procedures in accordance with department and company goalsFamiliarity with Design History requirements and documentsExperience with and, clear understanding of the Quality System Regulations and ISO 13485 requirementsLead/participate in projects/assignments that support continuous improvement efforts and department/company goalsProvide change control training (processes and system) to usersMaintain change control training materials up to dateCreate and maintain change control metrics and reports
#J-18808-Ljbffr
