Job Description

Job Title:

Quality Engineer

About the Company:

G&H Orthodontics, headquartered in Franklin, IN, is a manufacturer with more than 180 employees, and a worldwide supplier of orthodontic products and supplies. Our global footprint with customers and distributors stretches across more than 100 countries. We are ever-growing and are continually looking to add talented people to our team that are ready to help us grow even more. As a company, we value every employee and customer. We want our customers to feel like they are part of the G&H family.
G&H Orthodontics is always seeking talented and engaged employees with a desire to develop and grow their careers by demonstrating a determined positive attitude with a high drive to perform and succeed. The ideal candidate will bring an "authentic ownership" approach to their work and contributions at G&H.
To learn more about G&H Orthodontic career opportunities, visit

Careers | G&H Orthodontics

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The Quality Engineer is responsible for development and implementation of production quality control. The role will work closely with operations and product engineering to reduce scrap and drive continuous improvement activities within the manufacturing process to reduce customer complaints. This position will investigate internal and external quality issues, identifying root cause and corrective actions. The position will be responsible for using data analysis, data trending and periodic reporting. This position will perform process validations (IQ, OQ, PQ) and may support testing associated with product design verification or validation. This role will also support the Design and Development activities as the Quality representative for products throughout the lifecycle.



Bachelor of Science degree in engineering field (required) with at least two years of experience in medical device development/manufacturing (preferred). Demonstrated experience with authoring and managing manufacturing process validations, completion of IQ, OQ, PQ per medical device requirements and guidance. Strong analytical skills with an ability to use scientific knowledge and statistical methods to identify issues and assess the acceptability of system and process performance. Demonstrated knowledge and understanding of Statistical Process Controls. Experience with Corrective and Preventive Action process. Knowledge and understanding of ISO 14971 and risk management implementation. Strong communication, organization, project management, and time management skills are necessary, as well as strong interpersonal skills, and being team oriented with a positive attitude. Ability to prioritize work per business needs in a fast-paced environment. High degree of accuracy and attention to details. Must have excellent problem-solving skills. Ability to make decisions based on expertise and customer/business requirements. Ability to perform essential functions and responsibilities with little to no supervision. Excellent written and oral communication, technical writing and editing skills. High proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, etc.) and Adobe. LEAN/6 sigma experience (preferred). Knowledge and experience in interpretation of drawings, specifications, blueprints, etc. Demonstrated experience using inspection and measuring instruments such as calipers, micrometers, tensile strength testers (e.g. Instron), etc. * Able to follow instructions in all formats: written, verbal, and electronic.