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 several key processes within t he Quality Management System (QMS) to assure compliance to applicable standards. The Quality Systems Administrator will provide a significant portion of the data needed to maintain the QMS and also contribute to facility business performance metrics. The associate will be responsible for representing the company in a pr ofessional and exemplary manner. The Role will also support QMS updates 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 Device Master Files .
• Corrective and Preventive Action (CAPA):
• Documents and updates CAPA information related to QMS Issues .
• Initiates, tracks status , and completes (As required) CAPA s in the current company-wide system to effect change and 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 C omplaint status in the current company-wide system to effect change and 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 inquiries related 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.
• Own Matri x Management to reflect status for associate s Training within Value Streams and Work Cells.
• Serves as support resource for Technical Functions (Engineering and Quality)
• Performs other duties as required.
  
  

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

Apply Now