Supplier Quality Engineer III
Core
Ensure finished device quality and patient safety by managing supplier manufacturing processes, onboarding new suppliers, and driving compliance for Single-Use Devices and Capital Equipment in the Electrophysiology division.
Role type
Senior Supplier Quality Engineer (Medical Devices)
Builds
Sourced Finished Medical Devices (SFMD) for global distribution (via careerplan.io/jobs/563602811407126-supplier-quality-engineer-iii-at-bostonscientific)
Domain
Medical Devices / Electrophysiology / Regulatory Compliance
Required skills
Supplier qualification and performance monitoring, audit planning and execution, root cause analysis and corrective action planning, regulatory compliance knowledge, cross-functional collaboration, risk assessment
Preferred skills
Experience with Single-Use Devices and Capital Equipment, knowledge of global quality systems
Technologies
Quality management systems, audit tools
Responsibilities
Lead execution of quality deliverables to onboard finished medical device suppliers, generate and review quality plans and product specifications, plan and lead supplier audits to assess regulatory compliance, investigate and resolve non-conformances and field failures related to supplier materials
Seniority
Senior, hands-on IC
