Orascoptic Quality Engineer (On-Site Madison, WI)
Core
Leads technical quality engineering and validation activities for new product development, sustaining engineering, and manufacturing to ensure regulatory and customer compliance.
Role type
Quality Engineer (Medical Device Manufacturing)
Builds
Validated processes, equipment, software, and test methods for medical devices
Domain
Medical Device Manufacturing / Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation planning and execution, Risk management (FMEA), Statistical analysis (DOE, SPC, Gauge R&R), Root cause analysis, CAPA management, Supplier quality audits, Technical writing, Cross-functional collaboration
Preferred skills
Quality Engineer certification, Medical device industry experience, ERP/QMS system proficiency (MasterControl, Oracle)
Technologies
MasterControl, Oracle, Microsoft Office
Responsibilities
Lead validation activities (process, equipment, software, test methods), Serve as Quality representative for NPD and sustaining engineering, Lead investigations for nonconformances and complaints, Apply statistical tools to improve processes, Support supplier quality qualification and audits, Participate in regulatory and internal audits, Provide technical guidance to junior staff
Seniority
Mid-level, hands-on IC
