Principal Supplier Quality Engineer
Core
Driving supplier quality excellence to support the development and launch of innovative Aortic devices, ensuring robust component development, qualification, and release processes.
Role type
Principal Supplier Quality Engineer (New Product Development)
Builds
Innovative Aortic devices for CardioVascular Surgery
Domain
Medical Devices / Cardiovascular Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality engineering, global medical device regulations, contract manufacturer management, supplier qualification strategy, project management, supplier audit planning, change management, problem solving, mentoring
Preferred skills
Medical device engineering (disposable devices/capital equipment), Production Part Approval Process (PPAP), Lead Auditor certification (ISO 13485/9001), heart anatomy/physiology knowledge, manufacturing assembly processes
Technologies
ISO 13485, ISO 9001, PPAP
Responsibilities
Provide Pre-Market Supplier Quality Engineering support to New Product Development; Manage strategic Contract Manufacturers with accountability for product and process changes; Lead supplier's qualification strategy and manage quality deliverables for major/moderately complex projects; Plan and lead supplier audits to qualify suppliers and assess compliance; Mentor lower-level specialists on supplier quality deliverables; Drive cross-functional problem solving and communication with suppliers and internal stakeholders; Define Receiving Inspection requirements and associated test method validation
Seniority
Principal, hands-on IC with mentorship