Onsite Quality Engineer

Young-Innovations; Town of Grafton (WI); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k

Parental leave

Paid holidays

Paid time off

Short & long term disability insurance

Employee assistance program

Job summary

Young Innovations in Wisconsin seeks a Quality Engineer to provide technical quality support for Microbrush manufacturing operations. You will lead and support validation, CAPA, nonconformances, risk management, and continuous improvement, collaborating with Quality, Operations, and Engineering to resolve issues and improve product quality.

The ideal candidate has FDA-regulated manufacturing experience, strong data analysis skills, and the ability to own projects.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field; 3+ years FDA-regulated manufacturing experience.
• Experience with validation, CAPA, root-cause analysis, risk assessment, and quality systems.
• Knowledge of FDA and ISO quality standards; experience with medical devices a plus.

Responsibilities

• Provide technical quality support to manufacturing operations and cross-functional teams.
• Investigate nonconformances and support root-cause analysis and CAPA.
• Lead process qualification and validation activities (IQ/OQ/PQ) and test method validation.
• Support internal, customer, and regulatory audits and maintain regulatory compliance.
• Oversee calibration program and report quality and operational metrics.

Skills

Validation

CAPA

Root-cause analysis

Risk assessment

Quality systems

Data analysis

Education

Bachelor’s degree in Engineering, Science, or related field

Job description

Company 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 HealthWe 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 ManagerKey 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 SupportProvide 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 & ComplianceLead 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 ImprovementOversee 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 assignedWhat 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 SkillsBachelor’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 RequirementsTravel may be required periodically to support business needs, training, supplier activities, audits, or other quality-related initiatives.Work EnvironmentOffice EnvironmentThis 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 EnvironmentThis 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.