Company Overview
Young Dental is a leading designer, manufacturer, and marketer of consumables, instruments, and other items used in the dental industry. The products we create begin as a bright idea either from within our organization, backed by extensive research and development, or are generated by clinical professionals worldwide. Every product we manufacture is subject to strict quality control measures before being made available to a dental office. The result is a high-quality product that provides clinical benefits to the patient while providing efficacy, reliability, and comfort to the dental professional. Young Dental is a wholly owned subsidiary of Young Innovations, Inc. with sales in excess of $100 million and covers a broad portfolio of market-leading products across a variety of dental categories.

Primary Responsibilities: (80%)

• Monitor and manage the Complaint Handling process to ensure timely and accurate processing of complaints to fulfill the customer and regulatory requirements.
• Coordinate with customer
• service to get accurate and complete information about the complaint
• Analyze product complaint and make critical judgement on potential reportability. Report events to appropriate Regulatory Agencies, if required
• Work with operations and engineering to determine root cause and corrective/preventative actions
• Conduct document review (batch records, deviations, out of specification reports, etc)
• Prepare customer communications for complaints
• Review and close complaint files
• Generate complaint trending reports for analysis
• Lead monthly complaint meetings to analyze complaint data

Secondary Responsibilities: (20%)

• Assists in development and implementation of design of experiments and serves on problem solving teams
• Review production batch/packaging records for Quality Assurance release
• Draft, review, revise, and approve SOPs as relating to Complaint Handling and Quality assurance
• Participate in continuous approve of site quality systems
• Other duties as assigned

Key Requirements:

• Ability to perform data analysis and trending
• Able to manage time effectively to ensure deadlines are met
• Knowledge of regulatory standards, including but not limited to 21 CFR 820; 21 CFR 210/211; ISO 13485, ISO 14971, CMDR, MDD and JPAL is preferred.
• Regularly interfaces with:
• Entire Earth City Staff, YI Staff, and Contract Manufacturers.

Qualifications:

• Bachelor’s Degree in a technical field (science, engineering, mathematics)
• 3-5 years Quality Assurance experience in an FDA regulated field. Medical Device or Pharmaceutical Industry preferred. Experience in Regulatory will be considered.
• Strong attention to detail
• Able to work in a team environment
• Strong communication skills, both written and verbal