Uppsala Site Quality Leader
Core
Develop and maintain quality systems, rules, and processes to ensure fulfillment of internal and external requirements for medical technology products.
Role type
Site Quality Leader (1st or 2nd line manager)
Builds
Total quality management system for the business
Domain
Medical technology / Healthcare / Quality Management
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
ISO 13485 knowledge, process controls, quality management systems, root cause analysis, CAPA planning, complex problem analysis, resolution plan execution
Preferred skills
Strategic policy development, program/project leadership, consensus building, data analysis for recommendations
Technologies
ISO 13485, CAPA
Responsibilities
Drive compliance activities around a specific product and site, ensure quality and regulatory compliance while driving process effectiveness, represent the organization to external agencies, develop specialized depth in quality discipline, contribute to strategy and policy development, lead small projects with moderate risks, make decisions on moderately complex tasks impacting the function
Seniority
Senior, hands-on IC with management responsibilities