Senior Director, Quality Assurance
Core
Develops, interprets, and implements quality policies and systems for medical device manufacturing, ensuring compliance with global regulations and optimizing operational efficiency.
Role type
Senior Director, Quality Assurance (Medical Devices)
Builds
Global Quality Assurance Programs and compliant medical device products
Domain
Medical Device Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality system management, regulatory compliance (FDA, EU MDR, ISO 13485), risk management, supplier quality, validation, audit leadership, budgeting, team management, process improvement
Preferred skills
Lean and Six-Sigma, international team leadership, medical device manufacturing management
Technologies
Customized computer software programs, standard office packages
Responsibilities
Manage assigned quality assurance departments (Calibration, CAPA, Compliance, Audits, etc.), act as Quality System Management Representative for regulatory agencies, set strategy for global quality programs, lead the Senior Leadership Team on business goals, develop capital plans and budgets, review staff performance, coordinate emergency management and product investigations, partner with R&D on design control and new product transfer.
Seniority
Senior, executive leadership (Deputizing for VP)
