Sr. Supplier Quality Engineer
Core
Ensuring suppliers deliver quality parts, materials, and services for medical device manufacturing and new product development.
Role type
Senior Supplier Quality Engineer
Builds
Quality parts, materials, and services for Medtronic's cardiovascular, neuroscience, and surgical care technologies.
Domain
Medical devices / Healthcare technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier qualification and auditing, GMP compliance, Pre-Market Quality Engineering, Product Acceptance Sampling Strategy, Receiving Inspection requirements, Test method validation, Change control and CAPA, Risk management, Process validation (IQ/OQ/PQ), Technical documentation (SOPs, protocols, reports), Multidisciplinary team collaboration
Preferred skills
ISO 9001 and ISO 13485 certification, Lead auditor certification, ASQ CQE/CQA, Six Sigma Green/Black Belt, PPAP and sampling plans, Supplier performance monitoring, Manufacturing process knowledge, Regulatory audit participation, Production line transfer, Product design (DMR/DHF)
Technologies
QMS, ISO 13485, GMP, PPAP, IQ/OQ/PQ
Responsibilities
Ensure suppliers deliver quality parts, materials, and services; Qualify suppliers according to company standards; Monitor parts from acquisition through the manufacturing cycle; Develop and prioritize an auditing schedule for GMP and quality standards; Evaluate suppliers' internal functions and provide feedback; Provide Pre-Market Quality Engineering support to New Product Development; Provide technical guidance and quality compliance throughout the NPD lifecycle; Collaborate on Product Acceptance Sampling Strategy and Control Plans; Define Receiving Inspection requirements and test method validation.
Seniority
Senior, hands-on IC with project management and coaching responsibilities