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.

RESPONSIBILITIES:
• 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

QUALIFICATIONS:
• 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.

About Premier® Dental Products Company

Premier Dental is a global privately-held business dedicated to delivering inspired solutions for daily dentistry. Dental professionals have turned to Premier for over 100 years as a leader in bringing innovative products to market that improve their daily procedures, practices and patient outcomes.

The Premier Promise is the company’s promise to make it easy to do business with them, provide innovative, standard-setting solutions, be your Product Concierge—for knowledge and service, and make it right if they fall short. To learn more, visit: www.premierdentalco.com/promise