Quality Assurance - Quality Systems Administrator

POSITION TITLE: ​Quality Systems Administrator​ 

DEPARTMENT: ​Quality Assurance​ 

MAIN PURPOSE OF JOB: 

​​The primary purpose of this position is to support severalkey processes within the Quality Management System(QMS)to assure compliance to applicable standards. TheQuality Systems Administratorwill provide a significant portion of the data needed to maintain the QMSand also contribute to facility business performance metrics. The associatewill be responsible for representing the company in a professional and exemplary manner. The Role will also support QMSupdates and Continuous Improvement initiatives. ​ 

MAIN JOB RESPONSIBILITIES:    

• Adheres to Viant’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. 

• Document Control: 

• Develops and implements controls for the Viant Quality Management System (QMS) and product documentation. 

• Maintains quality records, administers and records change history, and implements approved QMS changes. 

• Updates Component and DeviceMaster Files. 

• Corrective and Preventive Action (CAPA): 

• Documents and updates CAPA information related to QMS Issues. 

• Initiates, tracksstatus, and completes (As required) CAPAsin the current company-wide system to effect changeand drive Continuous Improvement. 

• Complaints (Customer Direct and Field Related): 

• Documents and updates complaint files (DHR review and Product Evaluations) related to field complaints. 

• Initiates, tracks, and reports on Complaintstatus in the current company-wide system to effect changeand drive Continuous Improvement. 

• Compliance: 

• Administers correspondence related to registrations, certifications, and required files and listings related to Viant quality systems, product status,and procedures. 

• Assists with customer inquiriesrelated to quality agreements and the QMS. Notifies customers of updates to quality system status (new site, new certificates, etc.). 

• Business Metrics: 

• Generates periodic reports on quality system metrics including specific facility metrics and corporate summaries of common facility performance metrics. 

• Training: 

• Maintains and updates Training Database for Orientation (New Hires) and Overall Training.  

• OwnMatrix Management to reflect status for associatesTraining within Value Streams and Work Cells.  

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• Serves as support resource for Technical Functions (Engineering and Quality) 

• Performs other duties as required.