Senior Supplier Quality Engineer
Core
Ensures supplier quality, compliance, and process capability for Image Guided Therapy Devices across sustaining activities.
Role type
Senior Supplier Quality Engineer (Medical Devices)
Builds
Supplier process capability, validation readiness, and compliance with quality requirements for medical device manufacturing.
Domain
Medical Devices / FDA Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier Quality Engineering, APQP/PPAP execution, MSA/PFMEA/Control Plan/SPC/PV&V/FAI/IQ/OQ/PQ, supplier audits, supplier qualification, non-conformance investigations, CAPA/SCAR management, data analytics/KPIs, medical device regulations (21 CFR, ISO 13485, ISO 14971)
Preferred skills
Six Sigma DfX Certifications
Technologies
APQP, PPAP, MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, SCAR, CAPA
Responsibilities
Serve as primary Supplier Quality Engineering point of contact for on-site support; Lead APQP/PPAP execution for supplier transfers and changes; Facilitate Design for Excellence collaboration; Ensure Critical to Quality characteristics are defined and validated; Lead supplier audits and qualification activities; Lead supplier-related non-conformance investigations; Manage Supplier Corrective Action Requests; Drive systemic supplier improvement using performance data.
Seniority
Senior, hands-on IC