Principal Quality Engineer, Product Risk Management
Core
Lead end-to-end product impact assessments, risk evaluations, and containment activities for supplier recalls, safety notices, and quality-related market actions to ensure patient safety and regulatory compliance.
Role type
Principal Quality Engineer (Product Risk Management)
Builds
Product risk assessment frameworks, containment strategies, and recall management procedures for medical devices.
Domain
Medical Devices / Regulatory Compliance / Quality Engineering
Required skills
Risk management principles, FDA QSR (21 CFR Part 820), ISO 13485, CAPA, Supplier Quality Systems, Product impact assessment, Inventory containment, Cross-functional leadership, Technical solution development, Data trend analysis
Preferred skills
Medical Device Quality Engineering, Supplier Quality, Manufacturing Quality, Regulatory Affairs, Post-market quality activities, Complaint investigations, Global cross-functional environment experience
Technologies
FDA QSR, ISO 13485, CAPA, SCARs
Responsibilities
Evaluate supplier quality events and recalls; Lead product impact assessments; Coordinate containment across supply chain; Conduct risk assessments for patient safety and compliance; Develop bracketing strategies; Analyze quality event data for process improvements.
Seniority
Principal, technical subject matter expert with independent leadership