Director, Site Quality, El Paso Site
Core
Lead the Quality team at the El Paso site, developing and executing the Quality Management System to ensure compliance with global regulatory requirements for medical devices.
Role type
Director, Site Quality
Builds
Quality Management System and compliance readiness for medical device production
Domain
Medical Devices / Healthcare Quality
Deliverable
client delivery
Required skills
Quality Management System (QMS) development, regulatory compliance, risk-based approach, CAPA, root-cause analysis, team leadership, audit management, cross-functional partnership
Preferred skills
Master's degree or professional certification (ASQ, PMP), Spanish language proficiency, global regulatory experience, crisis management
Technologies
QMR, standard site quality scorecard
Responsibilities
Lead a team of quality professionals and develop talent; champion quality culture and drive objectives/metrics; implement regulations and ensure adherence through training; represent the company to external agencies and manage audits; prioritize quality actions using a risk-based approach with Manufacturing, Engineering, and Supplier Quality.
Seniority
Director, strategic leadership & team management
