Quality Engineer

Aimic Inc; Milwaukee (WI); On-site; USD 60,000 - 85,000; Full time

Job summary

Aimic Inc. in Milwaukee, WI seeks a quality/manufacturing engineer to ensure compliance with ISO 13485 and FDA regulations while supporting design transfer, production readiness, and launches.

You'll develop and maintain FMEA, CTQs, control plans, sampling, PPAP/FAI, and apply GR&R, process capability, and TMV methods to drive risk-based improvements across cross-functional teams.

Qualifications

• Bachelor's degree in Engineering, Quality, Science, or 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 preferred.

Responsibilities

• Ensure compliance with ISO 13485, FDA regulations, customer requirements, and QMS procedures.
• Review engineering drawings, specifications, BOMs, work instructions, inspection criteria, labeling, and packaging documentation.
• Support new product development, design transfer, production readiness, and manufacturing launch activities.
• Develop and maintain FMEA, CTQs, control plans, inspection strategies, sampling plans, PPAP, and FAI documentation.
• Apply statistical tools, including GR&R, process capability analysis, measurement systems, and data evaluation.
• Plan, execute, and document IQ/OQ/PQ, process validation, TMV, and other qualification activities.
• Support production quality, DHR/product release reviews, containment, rework, reinspection, and MRB dispositions.
• Investigate nonconformances, customer complaints/RMAs, deviations, and audit findings; support root cause analysis and CAPA.
• Analyze quality and manufacturing data, identify trends, drive risk-based improvements, and support cross-functional quality activities.

Skills

FDA regulations knowledge

ISO 13485 knowledge

Change control

Document control

ERP/MRP systems

Education

Bachelor's degree in Engineering/Quality/Science or related

CQE

Lean

Six Sigma

Tools

ERP/MRP systems

Job description

• 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 preferred.
• Ensure compliance with ISO 13485, FDA regulations, customer requirements, and Quality Management System (QMS) procedures.
• Review engineering drawings, specifications, BOMs, work instructions, inspection criteria, labeling, and packaging documentation.
• Support new product development, design transfer, production readiness, and manufacturing launch activities.
• Develop and maintain FMEA, CTQs, control plans, inspection strategies, sampling plans, PPAP, and FAI documentation.
• Apply statistical tools, including GR&R, process capability analysis, measurement systems, and data evaluation.
• Plan, execute, and document IQ/OQ/PQ, process validation, Test Method Validation (TMV), and other qualification activities.
• Support production quality, DHR/product release reviews, containment, rework, reinspection, and Material Review Board (MRB) dispositions.
• Investigate nonconformances, customer complaints/RMAs, deviations, and audit findings; support root cause analysis and CAPA.
• Analyze quality and manufacturing data, identify trends, drive risk-based improvements, and support cross-functional quality activities.