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.
-
Serves as support resource for Technical Functions (Engineering and Quality)
-
Performs other duties as required.
Otros detalles
- Tipo de pago Por hora
- Nivel de formación requerido Escuela secundaria
- Laconia, Nuevo Hampshire, EE. UU.