Supplier Quality Engineer
Core
Executes supplier qualification, audits, and quality system compliance within the Image Guided Therapies - Devices business.
Role type
Supplier Quality Engineer
Builds
Approved Supplier List, APQP/PPAP deliverables, supplier quality processes
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
APQP, PPAP, PFMEA, SPC, SCAR management, supplier audits, regulatory compliance (21 CFR, ISO 13485), defect analysis, root cause analysis
Preferred skills
Six Sigma DfX, data analytics/KPIs, ASQ certification
Technologies
MSA, FAI, IQ/OQ/PQ
Responsibilities
Conduct supplier audits for qualification and compliance; Qualify new suppliers for the Approved Supplier List; Execute APQP/PPAP activities including process validation; Initiate and monitor Supplier Corrective Action Requests (SCAR); Support supplier improvement initiatives; Investigate and disposition supplier non-conformances
Seniority
Entry-level to Mid-level, hands-on IC