Onsite Quality Engineer (40715)

Job DetailsJob Location: Grafton, WI 53024Company Summary:  At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™ We embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you’re looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.   Position Overview:  The Quality Engineer provides technical expertise and quality support to Microbrush’s manufacturing operations, leading and supporting initiatives related to validation, CAPA, nonconformances, risk management, quality systems, and continuous improvement. The ideal candidate is an analytical, detail-oriented, and collaborative professional with FDA-regulated manufacturing experience who can partner effectively with Quality, Operations, and Engineering to resolve issues, maintain compliance, and improve processes and product quality. You’ll like this role if: You enjoy problem-solving, data analysis, and continuous improvement. You thrive in a fast-paced manufacturing environment where priorities can shift. You enjoy wearing multiple hats and collaborating across Quality, Operations, and Engineering. You’re comfortable owning projects and working independently. You’re detail-oriented and motivated by quality, compliance, and measurable results. Why You’ll Love Working Here:  Medium sized company – not too big, not too small – just enough to get things done and see your impact. Did we say benefits? Full medical, dental, vision, 401k, parental leave, paid holidays, paid time off, short & long term disability insurance, employee assistance program, and more!  Meaningful engineering work: Take ownership of quality initiatives that directly impact product quality, regulatory compliance, and manufacturing performance. Who you’ll work with: Reports to: Quality Manager Key partners: Engineering, Quality, Operations, and Leadership teams. Cross-functional collaboration: Work closely with teams across the organization to investigate quality issues, support manufacturing, lead improvement initiatives, and maintain regulatory and quality standards. What You’ll Do:  Quality Engineering & Manufacturing Support Provide technical quality support to manufacturing operations and cross-functional teams. Investigate component, raw material, finished product, and process nonconformances and support root-cause analysis and corrective actions. Monitor quality and process performance using data analysis, statistical methods, and quality metrics. Perform risk assessments, including FMEA, and develop action plans to mitigate identified risks. Develop, maintain, and revise specifications for raw materials, components, and finished products. Support continuous improvement initiatives focused on defect reduction, process capability, product quality, and operational performance. Validation, Quality Systems & Compliance Lead the development, execution, and review of process qualification and validation protocols and reports, including IQ, OQ, and PQ activities. Lead test method validation activities and maintain associated documentation. Lead CAPA activities, including investigation, root-cause analysis, corrective action implementation, and effectiveness verification. Monitor deviations from Quality System processes and support timely investigation and resolution. Review procedures, quality records, and processes to identify compliance gaps and opportunities for improvement. Evaluate proposed technical and process changes and determine potential impacts to processes, procedures, materials, equipment, and product quality. Support internal, customer, and regulatory audits as needed. Maintain and apply knowledge of applicable FDA, ISO, and other regulatory and quality requirements. Quality Programs & Continuous Improvement Oversee the site calibration program and ensure equipment remains properly calibrated and maintained in accordance with established requirements. Partner with Quality and Operations leadership to collect, analyze, and report quality and operational performance metrics. Support Supplier Quality and Quality Control with investigations involving sourced raw materials, components, and finished products. Identify and implement opportunities to improve quality systems, manufacturing processes, and overall site performance. Participate in cross-functional projects and special initiatives related to quality, validation, process improvement, regulatory compliance, and manufacturing performance. Provide technical guidance and support to Quality, Operations, Engineering, and other cross-functional partners on quality-related matters. Other duties as assigned QualificationsWhat You’ll Bring:  Strong analytical, problem-solving, organizational, and communication skills. Ability to manage projects independently and collaborate cross-functionally. High-volume manufacturing experience preferred. Technical Skills  Bachelor’s degree in Engineering, Science, or related field with 3+ years of FDA-regulated manufacturing experience. Experience with validation, CAPA, root-cause analysis, risk assessment, and quality systems. Medical device, sterile packaging/ETO, CQE, or Six Sigma experience a plus. Travel Requirements Travel may be required periodically to support business needs, training, supplier activities, audits, or other quality-related initiatives.   Work Environment  Office Environment This position is based in an office environment and is primarily sedentary in nature. It requires regular use of standard office equipment, including computers, phones, photocopiers, scanners, filing cabinets, and fax machines. Some roles may involve wearing a headset and sustained computer use for 8 or more hours per day. Employees may be required to sit, stand, or walk for extended periods, and occasional bending, lifting, or carrying items up to 50 pounds may be necessary. Manufacturing/Distribution Environment This position operates in a manufacturing plant environment. The role routinely involves working around machinery, equipment, and moving mechanical parts. The facility may be subject to varying temperatures, loud noise levels, and airborne particles such as dust or chemical fumes, depending on the area of the plant. This role may require periods of standing, sitting, or walking throughout the workday. Occasional bending, lifting, or carrying items up to 50 pounds may be necessary.  Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, control, or feel; reach with hands and arms and talk. Hearing abilities required for this environment include being able to clearly hear and respond to audible alarms, production equipment, forklifts, and other machinery to maintain a safe work environment. Individuals must be able to distinguish and understand verbal communication including instructions, safety warnings, and team discussions, sometimes in an environment with moderate to high background noise.  Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.