Staff Quality Engineer
Core
Drive product and process quality compliance across manufacturing operations for medical instruments, leading investigations, continuous improvement, and new product introductions.
Role type
Staff Quality Engineer (Manufacturing)
Builds
Robust quality systems and production readiness for new medical device products
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, corrective and preventive actions (CAPA), quality management systems, supplier quality management, statistical process control, audit participation, material disposition, regulatory compliance
Preferred skills
Six Sigma Green/Black Belt, geometric dimensioning and tolerancing (GD&T), metrology equipment operation, medical device industry experience, statistical data analysis
Technologies
CMMs, calipers, micrometers, pin gauges
Responsibilities
Partner with cross-functional teams to monitor and improve product/process quality; Lead non-conformance investigations and CAPA implementation; Support new product launches and manufacturing scale-up; Collaborate with suppliers on quality issues and improvements; Evaluate engineering changes for regulatory compliance; Lead continuous improvement initiatives for scrap reduction and efficiency; Participate in internal/external audits and field actions
Seniority
Staff, hands-on IC with strategic leadership
