Process Quality Engineer (Onsite in Latham, New York)
Core
Ensures facility and product compliance with ISO 13485 and regulations, verifies products before distribution, and leads quality/process improvements for MRI magnet manufacturing.
Role type
Process Quality Engineer (Medical Device Manufacturing)
Builds
Compliant production processes and validated quality documentation for MRI magnet systems
Domain
Medical device manufacturing / MRI systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485 compliance, process and manufacturing equipment validation, PFMEA, control plans, statistical analysis tools, nonconformance management, CAPA, process documentation, Measurement System Analysis, Test Method Validation, Design History Review
Preferred skills
Change management, Lean Six Sigma certification
Technologies
None explicitly listed
Responsibilities
Create and execute documentation compliant with GDP, document and track nonconformances, support problem-solving and continuous improvement, maintain OJT documentation, ensure processes meet QMS requirements (Data Sheets, change control, deviations, PFMEAs, DHRs, CAPAs)
Seniority
Mid-level, hands-on IC
