Senior Engineer, Quality
Core
Senior Quality Engineer supporting manufacturing operations, process validation, and continuous improvement for the Prime Stretcher product line.
Role type
Senior IC quality engineer (manufacturing/validation)
Builds
Validated manufacturing processes and compliant medical device products
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
regulatory compliance, CAPA management, root cause analysis, change management, risk assessment, audit participation, Lean/Kaizen
Preferred skills
process/system validation, medical device industry experience, FMEA, statistical methods, metal fabrication
Technologies
FMEA, Fault Tree Analysis, Gauge R&R
Responsibilities
Review and approve validation and qualification documentation; Support nonconformance investigations and CAPA; Review and approve manufacturing process and equipment changes; Execute quality assessments and validation activities; Apply risk management tools; Participate in internal and external audits; Lead continuous improvement projects
Seniority
Senior, hands-on IC
