Sr. Director, Quality, Dispensing
Core
Sr. Director leading global pre and post market quality activities, design controls, risk management, and compliance for a broad portfolio of medical and non-medical dispensing products.
Role type
Sr. Director, Quality (Strategic Leadership & Hands-on IC)
Builds
Medication Management Solutions (MMS) products including Pyxis Medical Devices and non-medical electromechanical dispensing systems
Domain
Medical Technology / Healthcare / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), Design Controls, Risk Management, FDA compliance, Human Factors, Cybersecurity, Software Quality Engineering, Reliability Engineering, Test Method Development, Validation, Organizational Leadership, Cross-functional Negotiation, Change Management, Succession Planning
Preferred skills
AI/Agentic tools for quality process improvement, Open acquisitions integration, Manufacturing facility transfer
Technologies
FDA, Notified Body, Pyxis Medical Devices, Embedded Software, Analytics
Responsibilities
Lead global quality assurance and engineering programs for design, development, and transfer; Ensure compliance with design controls and regulations for medical and non-medical devices; Drive product risk management and safety assurance cases; Provide expert leadership during FDA and notified body inspections; Develop and deploy robust quality management systems; Manage succession planning and team building; Interface with FDA on pre-market activities; Identify and lead cross-functional teams to address field quality issues.
Seniority
Senior, Strategic Leadership & Hands-on IC