What are the responsibilities and job description for the Quality Assurance - Quality Systems Administrator position at Viant?
Join Our Team at Viant Medical – Laconia, NH
Quality Assurance – Quality Systems Administrator
Position Type: Full-time | On-site | First Shift
Why Viant Medical?
Comprehensive Benefits:
Medical, dental, and vision benefits effective on your first day of employment
Generous Paid Time Off (PTO) and 10 paid holidays annually
3 weeks plus 2 days of PTO
Company-paid life insurance
Shared Rewards Bonus Program: Quarterly incentive program valued up to $3,000 annually, prorated based on your start date.
401(k) with company match
Well-Being Programs:
Low-cost nutrition and mental health visits
Up to $150 off your gym membership annually
Discounted pet insurance for your furry friends
Access to financial planning sessions
Employee discount program with savings on electronics, home goods, and more
Discounted family caregiving support
Career Growth Opportunities:
Tuition reimbursement
On-site training programs
Defined career path for advancement
New hire onboarding training
MAIN PURPOSE OF JOB:
The primary purpose of this position is to support several key processes within the 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 professional 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) CAPAs 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 Complaint 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.).
Monitors our External Standards Revision with i2i Global.
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 Matrix Management to reflect status for associates Training within Value Streams and Work Cells.
Serves as support resource for Technical Functions (Engineering and Quality)
Performs other duties as required
