Onsite Quality Engineer — Drive Process & Product Quality

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

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.