Senior Manufacturing Quality Engineer - Hartland, WI
Core
Independently set quality standards, lead process validation and improvement, manage supplier quality, and ensure regulatory compliance for medical device manufacturing.
Role type
Senior Manufacturing Quality Engineer
Builds
Production processes, quality documentation (DMRs, design control files), and regulatory submissions (510K)
Domain
Medical Devices / Manufacturing Quality
Required skills
Statistical Process Control (SPC), Design of Experiments (DOE), CAPA management, Supplier Quality Management, Regulatory Compliance (21 CFR 820, ISO13485), Risk Management, Data Analysis
Preferred skills
Six Sigma/Lean concepts, Advanced Medical Device Industry Experience
Technologies
Microsoft Excel (Pivot tables, reporting), MS Office Suite
Responsibilities
Manage development and implementation of process control and validation methods; Design complex experiments to analyze variation; Direct supplier quality programs and lead qualifications; Lead investigations of non-conformances and develop corrective actions; Ensure compliance with domestic and international regulations; Provide quality expertise in Product Development and Design Control.
Seniority
Senior, hands-on IC