Onsite Quality Engineer: Validation, CAPA & Compliance

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

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.