Onsite Quality Engineer (40715)

Young Innovations • Grafton, WI

4d • Onsite

About The Position

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.

Requirements

• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to manage projects independently and collaborate cross-functionally.
• High-volume manufacturing experience preferred.
• Bachelor’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.

Nice To Haves

• Medical device, sterile packaging/ETO, CQE, or Six Sigma experience a plus.

Responsibilities

• 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.
• 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.
• 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

Benefits

• Full medical, dental, vision, 401k, parental leave, paid holidays, paid time off, short & long term disability insurance, employee assistance program, and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level