JOB TITLE: Quality Assurance Analyst
REPORTS TO: Director, Quality Assurance & Regulatory Affairs
JOB DESCRIPTION: The Quality Assurance Analyst will provide critical support to the quality and regulatory function at Premier Dental Products Company. This role works in partnership with the Quality Assurance & Regulatory Affairs department, product development, manufacturing, operations, marketing/sales and others, to ensure processes are documented accordingly. This role will ensure downstream product compliance to regulatory and ISO requirements.
• Analyze quality data such as data collected from surveys, complaints, feedback, etc.
• Search, analyze and report on quality data submitted to regulatory agencies regarding competitor products
• Compile reports on a scheduled basis on product feedback collected from post market data
• Data entry of new or revised UDIs within regulatory UDI systems
• Assist in the update of logs and databases within Premier network drives
• Assist in the updating or creation of SOPS, Work Instructions, and Forms
• Interact effectively with functional heads within product development, manufacturing, operations, marketing/sales and other stakeholders
• Provide oversight in the review of completed documents and forms
• Work closely with suppliers, manufacturing facilities and customers to address issues identified for improvement or resolution
• Facilitate training and educate employees in regulatory and quality requirement as needed
• Apply a risk based approach to all applicable elements of the Quality Management System
• Perform other duties as required
• 2+ years of Quality System experience in a medical device company
• Bachelor’s degree in a relevant field
• Proficiency in Microsoft Office programs such as Microsoft Word, Excel, Powerpoint
• Proficiency in Adobe Acrobat and other software
• Must possess excellent interpersonal, communication (written and verbal), problem solving and negotiating skills
• Excellent organizational, prioritization and time management skills
• Experience in training others in the quality management system
• Knowledge in quality management systems, process improvement utilizing statistical problem solving techniques, and quality tools.
Contact Karen Giannone if interested, or if you need more information.