Onsite Quality Engineer

Young Innovations; Town of Grafton (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Young Innovations is seeking a Quality Engineer to provide technical quality support to Microbrush’s manufacturing operations, leading validation, CAPA, nonconformances, risk management, quality systems, and continuous improvement. The ideal candidate is analytical, detail-oriented, with FDA-regulated manufacturing experience, able to partner with Quality, Operations, and Engineering to resolve issues and improve product quality. You will also monitor quality performance and drive improvements.

Qualifications

• FDA-regulated manufacturing experience required.
• Analytical and detail-oriented with problem-solving mindset.
• Ability to lead CAPA and validation activities.

Responsibilities

• Provide technical quality support to manufacturing operations and cross-functional teams.
• Investigate nonconformances and support root-cause analysis and corrective actions.
• Monitor quality using data analysis, statistical methods, and quality metrics.
• Lead IQ/OQ/PQ process validation activities and maintain associated docs.
• Lead CAPA investigations, actions, and effectiveness verification.
• Monitor quality system deviations and support audits and compliance.

Skills

Quality engineering

Data analysis

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in a 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 Health™

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 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