Quality Engineer I

Requirements

• A passion for quality and continuous improvement.
• Curiosity and a data-driven mindset.
• The ability to collaborate effectively across multiple departments.
• A proactive approach to problem-solving and process improveme nts

Benefits

Additional Information

Ultradent Products Inc, a 47-year dental manufacturing company is seeking out a Quality Engineer I . This person is responsible for ensuring that products meet established quality standards while minimizing quality costs and maximizing customer satisfaction. This role supports product and process quality throughout development, validation, manufacturing, and post-market activities. The Quality Engineer I assists in identifying, documenting, tracking, and resolving quality issues while ensuring compliance with applicable procedures, regulations, and industry standards. This position collaborates cross-functionally with Engineering, Manufacturing, Quality, and Supplier partners to support continuous improvement initiatives, risk management activities, process development, validation efforts, and root cause investigations. The Quality Engineer I compiles and analyzes technical data, prepares reports, and presents findings to stakeholders at all levels of the organization. This position requires onsite presence Monday-Friday in the South Jordan location and will report to the Quality Engineering Manager. Essential Duties and Responsibilities Participate in product design and process development projects to ensure design controls and manufacturing processes meet quality and regulatory requirements. Develop, execute, and document process validations, method validations, and related qualification activities. Assist in the design and development of manufacturing processes, inspection methods, measurement systems, and testing tools. Support supplier quality initiatives by collaborating with suppliers and Supplier Quality Engineers to improve quality performance and assist with supplier qualification and validation activities. Participate in investigations related to customer complaints, corrective and preventive actions (CAPA), nonconformance reports (NCRs), and other quality events. Conduct root cause analyses and support implementation of effective corrective actions. Assist with internal and external audits as requested by Quality Engineering leadership. Partner with Engineering and Manufacturing teams to develop data-driven process controls and identify critical process variables for continuous improvement initiatives. Analyze quality and manufacturing data using statistical methods and present findings through technical reports and presentations. Support risk management activities and assist senior Quality Engineers with process development and quality improvement projects. Complete ongoing technical and quality system training to maintain compliance and professional development. Assist in establishing, tracking, and reporting quality metrics and objectives across the organization. Support compliance with applicable regulatory and quality system requirements. Required Knowledge and Skills Knowledge of quality systems and regulatory requirements, including: cGMP 21 CFR Parts 210, 211, and 820 ISO 13485 ISO 14971 MDD, MDR, and MDSAP Understanding of quality system development, documentation, implementation, and maintenance. Basic knowledge of manufacturing statistics and quality engineering tools, including: Statistical Process Control (SPC) Control Charts Root Cause Analysis Design of Experiments (DOE) Gauge R&R Proficiency with Microsoft Office applications. Familiarity with Oracle, Agile, Adobe, and Minitab or similar systems. Working knowledge of, or willingness to learn, one or more programming languages such as Python, R, SQL, or C++. Strong analytical and problem-solving skills. Excellent organizational, project management, and time management abilities. Ability to work independently while managing multiple priorities. Strong written and verbal communication skills, including technical writing and presentation skills. Ability to adapt quickly in a dynamic and collaborative environment. Education and Experience Preferred: Bachelor's degree in Engineering, Data Science, Physical Sciences, Life Sciences, or a related technical field from an accredited university. Academic or professional experience involving technical writing, statistical analysis, and presentation of technical data. Preferred Technical Disciplines Candidates should demonstrate proficiency in one or more of the following areas: Physics Electronics Measurement Sciences Physical Chemistry Analytical Chemistry Chemical Engineering Electrical Engineering Mechanical Engineering Data Science

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