Senior Quality Manufacturing Engineer - Hartland, WI
Core
Setting quality standards, validating processes, and ensuring regulatory compliance for medical device manufacturing.
Role type
Senior Quality Manufacturing Engineer
Builds
Medical device products compliant with FDA and international regulations
Domain
Medical Devices / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical Process Control (SPC), experimental design, root cause analysis, supplier quality management, regulatory compliance (21 CFR 820, ISO13485), CAPA development, risk management, MS Excel (advanced)
Preferred skills
Six Sigma/Lean concepts, 5+ years in Medical Devices/Drugs
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Develop and implement process control and validation methods; Design complex experiments to analyze process variation; Lead supplier qualification and quality improvement programs; Generate Device Master Records and support 510K submissions; Investigate non-conformances and lead CAPA; Ensure compliance with domestic and international regulations.
Seniority
Senior, hands-on IC