Sr Supplier Quality Engineer
Core
Lead supplier quality activities to ensure purchased materials, components, and services meet quality, regulatory, and business requirements for medical devices.
Role type
Senior individual contributor supplier quality engineer
Builds
Qualified suppliers, validated processes, compliant finished goods and components
Domain
Medical device manufacturing and supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
supplier qualification, process validation, risk management, CAPA, nonconformance management, supplier audits, statistical analysis, change control, regulatory compliance
Preferred skills
statistical methods, process capability analysis, DOE, MSA, SPC, validation principles, ERP/PLM systems
Technologies
ISO 13485, China GMP, PPAP, CAPA, DOE, MSA, SPC
Responsibilities
Lead supplier quality activities across new product introduction and sustaining operations; Qualify, monitor, audit, and requalify suppliers; Manage PPAP for finished goods and components; Lead investigations into supplier-related nonconformances and drive CAPA; Partner with R&D, manufacturing, regulatory, and sourcing to support design transfer and supplier transfers; Monitor supplier performance and drive improvements.
Seniority
Senior, hands-on IC with project leadership