Principal Supplier Quality Engineer, Contract Manufacturing (CMO)
Core
Provide end-to-end quality oversight for Contract Manufacturing Organizations (CMOs) producing finished medical devices, ensuring compliance and performance from design transfer to distribution.
Role type
Principal Supplier Quality Engineer (IC)
Builds
Supplier quality roadmaps, corrective action plans, and continuous improvement processes for CMOs.
Domain
Medical Devices / Contract Manufacturing
Required skills
Supplier Quality Engineering, Quality Management Systems (QMS), Root Cause Analysis, CAPA/SCAR management, Regulatory Compliance (FDA/GMP/ISO), Risk Assessment, Process Validation, Stakeholder Management, Data Analysis, Lean Manufacturing, FMEA, Statistical Process Control
Preferred skills
Medical Device Industry Experience, CMO Management, Electronics/PCBA Knowledge, Six Sigma (DMAIC), Project Management Certification, ASQ Certification, Lead Auditor Certification
Technologies
Microsoft Office Suite, QMS Software, Audit Tools
Responsibilities
Monitor supplier performance via metrics and audits; lead CAPAs and complaint investigations; develop supplier quality roadmaps; partner on design transfer and process validation; analyze quality trends to drive improvements; ensure regulatory compliance for finished devices.
Seniority
Principal, strategic IC with cross-functional leadership
