Production Quality Engineer
Core
Monitoring production quality KPIs, planning and performing validations for processes and tools, failure investigations, and supporting NPI processes for medical device manufacturing.
Role type
Production Quality Engineer
Builds
Home Sleep Apnea Test devices (WatchPAT®)
Domain
Medical devices / Respiratory sleep disorders
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Failure investigation, KPI monitoring and reporting, NCR/CAPA management, Root Cause Analysis (RCA), Validation planning and execution, Production line problem solving, Mechanical assemblies knowledge, PCBA manufacturing requirements
Preferred skills
ERP and PLM systems knowledge, Medical Regulatory knowledge
Technologies
ERP, PLM
Responsibilities
Failure investigation in production together with engineering, Collect and analyze quality data to determine yield and failure trends, Manage SCARs and MRB monitoring, Prepare monthly and weekly quality presentations based on KPI follow up, Support R&D and Engineering in integrating new processes in production and in NPI
Seniority
Mid-level, hands-on IC