Senior Quality Engineer

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. ## About the Role As a Senior Quality Engineer, you will lead quality improvement initiatives across product development, manufacturing, supplier quality, and quality systems. You'll work closely with cross-functional teams to solve complex quality challenges, drive corrective actions, and ensure compliance with industry standards and regulatory requirements. This is an excellent opportunity for a quality professional who enjoys data-driven problem solving, continuous improvement, and making a meaningful impact in a regulated manufacturing environment. ## What You'll Do - Partner with cross-functional teams on new product and service development projects, ensuring quality requirements are met throughout the product lifecycle. - Lead investigations, root cause analyses, corrective actions, and continuous improvement initiatives. - Develop and implement statistical methods including sampling plans, process capability studies, SPC, trend analysis, and designed experiments. - Analyze quality data and recommend process and product improvements. - Drive quality system enhancements and support ongoing compliance initiatives. - Lead supplier quality audits and corrective action programs. - Support internal and external audits, including regulatory and certification audits. - Evaluate and disposition nonconforming materials and processes. - Develop quality metrics, analyses, and reports to measure system performance. - Train and mentor employees on quality principles, problem-solving methodologies, and statistical techniques. - Collaborate with teams across manufacturing, operations, engineering, and supply chain to improve quality performance. ## What We're Looking For ### Required Qualifications - Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field. - 6–10 years of combined Quality Engineering, Manufacturing Engineering, and/or Quality Systems experience. - 6–10 years of experience working within an ISO-certified environment. - Strong knowledge of quality tools, methodologies, and continuous improvement practices. - Experience leading root cause investigations and corrective actions. - Excellent analytical, organizational, and problem-solving skills. - Strong verbal and written communication skills. - Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint. ### Preferred Qualifications - Experience in medical device, healthcare, or other regulated industries. - Knowledge of FDA Quality System Regulations, GMP, and related regulatory requirements. - ASQ certification or similar quality certification. - Experience with statistical analysis software and Visio. - Prior experience leading or supervising quality personnel. ## What Will Make You Successful - A passion for continuous improvement and operational excellence. - The ability to influence and collaborate across functions. - Strong data analysis and decision-making skills. - A proactive approach to identifying and solving quality challenges. - The ability to manage multiple projects and priorities in a fast-paced enviro…