Supplier Development and Quality Engineer
Core
Develop and strengthen the supplier base for Elekta's Neuro and Brachy business lines, ensuring quality, delivery, and performance of components for precision radiation medicine systems.
Role type
Senior Supplier Development and Quality Engineer
Builds
Precision radiation medicine systems (Leksell Gamma Knife) and associated supply chain components
Domain
Medical device manufacturing / Radiation therapy / Regulated industry
Required skills
Supplier quality management, root cause analysis, corrective action planning, supplier audits, continuous improvement, risk management, quality control, supplier documentation management
Preferred skills
Lead Auditor certification, knowledge of ISO 13485/9001/14001/14971/21 CFR Part 820, 8D/5 Whys/Lean/Six Sigma methodologies
Technologies
ISO 13485, ISO 9001, ISO 14001, ISO 14971, 21 CFR Part 820, 8D, 5 Whys, Lean, Six Sigma
Responsibilities
Manage supplier quality issues and ensure effective containment, root cause analysis and corrective action; Monitor and improve the quality performance of assigned suppliers; Conduct supplier approval, surveillance, capability and quality management system audits; Lead supplier development and continuous improvement initiatives; Plan and document Supplier First Article Inspections and Production Part Approval Processes; Perform and administer required quality control activities for installed Leksell Gamma Knife systems
Seniority
Senior, hands-on IC (via careerplan.io/jobs/R2026-1311-supplier-development-and-quality-engineer-at-elekta)
