Ingeniero de Calidad
Core
Develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Role type
Senior Specialist, Quality Assurance
Builds
compliant and cost effective quality system
Domain
Healthcare / Manufacturing
Required skills
root cause analysis, regulatory compliance, SOP development, audit support, change control assessment, internal program execution, external reporting, stakeholder guidance
Preferred skills
mentoring junior specialists, leading SOP development, complex quality issue resolution
Technologies
N/A
Responsibilities
Execute internal programs to define Quality guidelines and track adherence; respond to significant quality issues and conduct root cause analyses; support the Change Control Program by assessing QA implications; update standard operating procedures in response to product changes and regulatory developments; prepare responses to regulatory queries, audits, and corporate audits; support quality audits and inspections of distribution centers; provide guidance to junior level Specialists on complex issues.
Seniority
Senior, hands-on IC
