Onsite Quality Engineer

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™

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.

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 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.

• 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.

• 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.

• 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…