Quality Engineer in Milwaukee

Job Description

Quality Engineer – Job Summary

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1. Qualifications: Bachelor's degree in Engineering, Quality, Science, or a related technical field; 2–5 years of manufacturing engineering or quality assurance experience; knowledge of FDA regulations, ISO 13485, change control, document control, and ERP/MRP systems. CQE, Lean, or Six Sigma certification is .

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2. Ensure compliance with ISO 13485, FDA regulations, customer requirements, and Quality Management System (QMS) procedures.

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3. Review engineering drawings, specifications, BOMs, work instructions, inspection criteria, labeling, and packaging documentation.

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4. Support new product development, design transfer, production readiness, and manufacturing launch activities.

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5. Develop and maintain FMEA, CTQs, control plans, inspection strategies, sampling plans, PPAP, and FAI documentation.

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6. Apply statistical tools, including GR&R, process capability analysis, measurement systems, and data evaluation.

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7. Plan, execute, and document IQ/OQ/PQ, process validation, Test Method Validation (TMV), and other qualification activities.

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8. Support production quality, DHR/product release reviews, containment, rework, reinspection, and Material Review Board (MRB) dispositions.

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9. Investigate nonconformances, customer complaints/RMAs, deviations, and audit findings; support root cause analysis and CAPA.

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10. Analyze quality and manufacturing data, identify trends, drive risk-based improvements, and support cross-functional quality activities.

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