JOIN OUR TEAM AT HUFRIEDYGROUP – INNOVATING EXCELLENCE IN DENTAL INSTRUMENT MANUFACTURING:

HuFriedyGroup is a leading manufacturer of dental instruments and infection prevention products. Our 10,000-plus products, hand-crafted by highly skilled artisans, are known for their precision, performance, longevity, reliability, and quality. To help dental professionals be The Best in Practice, HuFriedyGroup provides a unique combination of world class products, value-added services, clinical education, and dental community platforms that result in superior clinician performance and enhanced safety for dental professionals and their patients. Working at HuFriedyGroup is so much more than a job, as every employee has a part in driving and supporting the organization’s inspirational vision to be a global force in advancing dental performance through Best-In-Practice dentistry that improves lives around the world.

SUMMARY OF POSITION

The Quality Specialist is responsible for assisting in the administration of the quality functions at the Lawrenceville GA site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role will be responsible for document and master data control transactions, site record retention, calibration and inspection activities, facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.

• Complete document and master data control transactions.
• Perform customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHR’s and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration program.
• Support site inspection activities and recordkeeping.
• Support internal and external audits.
• Support supplier quality assessment activities.
• Perform customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.

FUNCTIONAL KNOWLEDGE, SKILLS & ABILITIES:

• 1-2 years combined experience in Manufacturing/Quality Engineering and/or Quality Systems.
• Associate degree preferred.
• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement
• Experience working on cross-functional teams and on own initiative
• Demonstrated excellent organizational, oral and written communications skills

• Complete document and master data control transactions.
• Perform customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation.
• Review DHR’s and support batch record release.
• Manage record retention practices within the site.
• Manage site calibration program.
• Support site inspection activities and recordkeeping.
• Support internal and external audits.
• Support supplier quality assessment activities.
• Perform customer complaint investigations and complete complaint documentation.
• Facilitate CAPA and NCR investigations and may coordinate investigation documentation