Senior Quality Manager-Advanced Imaging
Core
Lead the Quality Management System (QMS) and Design Assurance functions to ensure safe, effective, and compliant Image Guided Therapy products throughout the product lifecycle.
Role type
Senior functional manager for Quality and Design Assurance
Builds
Safe, effective, and compliant Image Guided Therapy products
Domain
Medical Devices / Advanced Imaging
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS compliance, Design Assurance, regulatory inspection leadership, team functional management, risk management, CAPA/Nonconformance management, data analysis for quality KPIs, strategic quality initiatives
Preferred skills
Lean, Six Sigma, Quality Engineering
Technologies
ISO 13485, ISO 14971, 21CFR, EU MDR, GMP, GDP
Responsibilities
Lead QMS and Design Assurance functions; oversee compliance with global regulations (FDA, ISO, EU MDR); serve as primary representative for regulatory inspections and audits; establish and improve quality processes; lead and develop the quality organization; monitor quality metrics and drive data-based decisions; partner cross-functionally to resolve quality issues; oversee design controls, verification, validation, and process validation; lead complex investigations, root cause analyses, and CAPA activities; drive audit readiness and operational excellence initiatives; manage departmental objectives and budgets.
Seniority
Senior, hands-on IC with functional management responsibilities