Onsite Quality Engineer

Young Innovations•Grafton, WI

70d•Onsite

About The Position

The Quality Engineer provides technical expertise and quality support to Microbrush manufacturing operations. The role leads and supports initiatives involving validation, CAPA, nonconformances, risk management, quality systems, and continuous improvement. The position works with Quality, Operations, and Engineering to investigate issues, maintain regulatory compliance, and improve processes and product quality. It suits an analytical, detail-oriented, collaborative professional who is comfortable working independently, managing projects, and adapting to changing priorities in a fast-paced manufacturing environment. The role supports manufacturing operations, investigates nonconformances, analyzes quality and process data, assesses risk, and maintains product specifications. It leads process and test-method validation, CAPA activities, and site calibration oversight; reviews quality systems and proposed changes; and supports audits, supplier investigations, and continuous-improvement projects. The position reports to the Quality Manager and works with Engineering, Quality, Operations, and Leadership teams. Travel may periodically be required for business needs, training, supplier activities, audits, or other quality-related initiatives.

Requirements

Bachelor’s degree in Engineering, Science, or a related field.
At least 3 years of FDA-regulated manufacturing experience.
Experience with validation, CAPA, root-cause analysis, risk assessment, and quality systems.
Strong analytical, problem-solving, organizational, and communication skills.
Ability to manage projects independently and collaborate cross-functionally.

Nice To Haves

High-volume manufacturing experience.
Medical device experience.
Sterile packaging/ETO experience.
CQE experience.
Six Sigma experience.

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 is 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 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.
Perform other duties as assigned.