Quality Specialist

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.

This position provides support to the Document Control function by processing document and data requests and completing administrative responsibilities. Delivers efficient and accurate data entry and document deliverance in support of the organization’s day-to-day operations, compliance efforts, etc.

Duties

• Processes Document Control requests for day-to-day activities. Requests may include quality system documentation, material master data creation/changes, BOM/router creation/changes, engineering changes, and other data entry requests.

• Supports the department in gathering data and preparing documentation .

• Supports the administration of the electronic document management system to ensure compliance with applicable regulatory requirements following established processes and change control procedures for proper formatting, review and approval. Upload issued documents to Hu-Friedy intranet.

• Utilizes the automated data entry tool for entry of Material Master, BOM’s, Routers, etc. into the ERP system.

• Supports and is knowledgeable of all areas of Hu-Friedy Operations.

• Functions as liaison between Document Control and various business units within the organization.

• Administers the training system to provide quality system training to Hu-Friedy employees. Works with document owners to ensure proper curriculum is assigned to departments. Follows up periodically with employees to ensure training is completed on time to maintain compliance.

• Prepares monthly reports, status reports, quality system management reports, and/or researching outstanding change requests. Follows up when necessary to assure that all requests are approved within designated time frame.

• Supports Regulatory UDI compliance by administrating the data collection and data upload process to GUDID using a combination of a document management system and a GUDID submission solution provider. Investigate and resolve discrepancies in data by working with appropriate personnel as needed.

• Supports document and data analysis efforts and resolution implementation to ensure compliance with quality standards and procedures. Supports with identifying the root cause of data errors and implementing procedural corrections to ensure data integrity of MasterControl and SAP.

• Responsible for administrating and maintaining the department’s SharePoint site and its contents.

• Conducts end-user training on Document Control procedures and systems as needed. Develops training materials for both internal and external use.

• Handle issues and requests from internal customers in a timely and accurate manner.

• Participates in Hu-Friedy’s internal audit program as assigned.

• Completes other responsibilities as assigned.

This position requires an individual with:

• 0-2 years in an administrative role (preferably in a regulated medical device environment).

• College degree or equivalent experience preferred.

• High degree of initiative and must work with minimal supervision, balancing a variety of tasks and priorities. Seeks to help others when own work is completed.

• Excellent typing, word processing, spelling, and proofreading skills. MS Office – Intermediate Excel, Intermediate Word, Intermediate PowerPoint required.

• Must be able to perform functions including set up spreadsheets, enter data, use sort and graphing functions. Must be able to perform functions including set up word processing documents, creating and modify tables within documents, import objects, format documents, use header/footer function, and pagination.

• Ability to use ERP-type software package (for BOM and router maintenance, general information inquiry, etc.) a strong plus. Experience in SAP and Document Control solutions such as MasterControl preferred.

• Excellent organizational skills due to the numerous internal customers with varying and unique requirements/priorities. Must understand the nature of the work and the impact it has on the department to which it pertains.

• Job requires strong attention to detail for typing, data entry, and proofreading. Job has a wide variety of tasks and procedures to learn, remember and perform accurately.

• Excellent English communication skills, written and verbal required. May be called upon to edit draft documents for readability, grammar, etc.

• Strong interpersonal skills and a “service to the customer” orientation is a must.

Benefits:

Healthcare, Vision, Dental, 401K Match, PTO, Company Holidays

Equal Employment Opportunity & Accessibility StatementHuFriedyGroup is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We prohibit discrimination and harassment of any kind based on race, color, religion, age, gender, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
If you require reasonable accommodations to apply for a position, participate in the recruitment process, or perform essential job functions, please contact us at 773-868-5534. We are committed to supporting you throughout your journey with HuFriedyGroup!