Ingeniero Sr de Calidad
Core
Develops and implements quality policies, procedures, and processes to ensure medical device products and services comply with regulatory standards and specifications.
Role type
Senior Quality Engineer (Molding)
Builds
Medical device manufacturing processes and quality assurance systems
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, validation of processes and test methods, regulatory compliance (ISO13485, FDA), internal auditing, continuous quality improvement, cost reduction project management, team mentoring, analytical problem solving
Preferred skills
experience in sustainability initiatives, advanced English proficiency
Technologies
ISO13485, FDA regulations, validation protocols
Responsibilities
Lead quality assurance processes for manufacturing operations, respond to complaints and non-compliance, conduct trending analysis and develop management reports, serve as internal auditor and lead external regulatory auditors, facilitate problem solving and root cause investigations, mentor junior employees, validate and maintain test methods and measurement equipment
Seniority
Senior, hands-on IC with leadership responsibilities