Supplier Quality Engineer
Core
Ensuring supplier quality and compliance for medical device manufacturing by inspecting raw materials, managing supplier relationships, and resolving quality issues.
Role type
Supplier Quality Engineer
Builds
Medical device products and components
Domain
Medical Technology / Healthcare Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
raw material inspection, supplier audits, regulatory compliance (FDA/NSAI/MDSAP), continuous improvement methodologies, supplier relationship management, process validation knowledge, documentation management, change request coordination, performance metrics monitoring
Preferred skills
Certified Quality Auditor, ISO 13485:2016 experience, medical device industry experience, IQ/OQ/PQ/DOE knowledge
Technologies
inspection equipment, Supplier Quality Agreements (SQA), Approved Supplier Lists (ASL)
Responsibilities
Perform incoming raw material inspections and approve material releases; conduct supplier audits and assessments; coordinate disposition of nonconforming materials; support internal and external regulatory audits; maintain supplier documentation and ASL; communicate specification changes to suppliers; monitor supplier quality performance metrics; lead continuous improvement initiatives
Seniority
Entry-level to Mid-level, hands-on IC