Principal Quality Engineer, Product Risk Management
Core
Lead end-to-end product impact assessments, risk evaluations, and containment actions for supplier recalls, safety notices, and quality events 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 processes 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 problem solving, 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, recalls, and nonconforming product notifications; Lead product impact assessments for recalls and safety notices; Coordinate containment activities across Manufacturing, Supply Chain, and Regulatory Affairs; Conduct risk assessments involving patient safety and business continuity; Analyze quality event data to identify risk reduction opportunities; Develop technical solutions for complex quality and compliance challenges.
Seniority
Principal, technical subject matter expert with independent decision-making and mentorship