HuFriedyGroup is the dental industry leader in infection prevention solutions, premium instrumentation, and service and support programs that help dental professionals be the best in practice. As the dental division of Cantel, HuFriedyGroup encompasses a vast array of brands and products, integrated together to deliver full service and support - a complete circle of protection - to dental practices around the globe. We are dedicated to employee engagement and development, diversity and inclusion, wellness, and social responsibility. Our core values and well-defined culture are evident in daily life at HuFriedyGroup and continue to shape the success of our business.
About the role
Support the quality system and associated quality assurance functions. Provide support to Manufacturing Operations by resolving quality related issues, improving product quality delivery, and reporting quality performance metrics. Ensure timely release of components/materials through in process production and finished product inspections to support Manufacturing Operations. #CB
What you will do
Inspects, audits, and reports on components/materials using variable or attribute measuring instruments and techniques to ensure conformance with Crosstex's specifications and quality standards.
Perform incoming material, in-process, and finished good inspections.
Maintain data records and batch files of inspected components and materials.
Identify, document, and report product non-conformances.
Provide feedback to Operations through reportable metrics and daily collaborative dialogue
When necessary provide support to quality activities and projects for other Crosstex locations
Look for opportunities to improve materials, processes, and products.
Maintain compliance with FDA, ISO, and other applicable regulatory body requirements.
Other duties as assigned.
What we are looking for
Must be a high school graduate, with minimum of 2 years' quality assurance experience or equivalent experience within a manufacturing or medical environment
Must possess intermediate PC skills, such as using Microsoft Word and Microsoft Excel.
Must be able to read and understand product requirements. Experience with sampling techniques and safety information preferred.
Must have strong oral and written communication skills while working within a dynamic crossfunctional team
Familiarity with FDA Quality System Regulations, Good Manufacturing Practices, ISO 13485, and Good Laboratory Practices is preferred.
This position requires that work be performed in warehouse, office, and controlled environment areas.
Familiarity with document control and root cause investigations is preferred.
Understanding of audit processes and etiquette.
Individual must be able to walk, stand, reach both above and below shoulder height, and pull, push or lift up to 50 pounds. Occasional bending, stooping, and crouching is required.
This position requires frequent repetitive movement of both hands (firm or fine grasping) and good hearing, vision and color distinction.