Andreina Angulo Morales

My engineering background and experience have taught me that true innovation occurs when it is grounded in robust regulatory compliance. Having worked in environments regulated by ISO 13485 and GMP standards, I view quality as a culture of commitment to excellence, rather than a mere technical verification, ensuring solutions that meet the industry’s most stringent standards. I am a professional with experience in managing non-conformities (NCR), supporting corrective and preventive actions (CAPA), applying root cause analysis (RCA), change management, documentation control, and Lean methodologies (5S, Kaizen).

I am focused on ensuring product integrity and the rigorous maintenance of quality management systems.

Medtronic | Manufacturing Quality Analyst | 2024–2025

-I managed the full non-conformance (NCR) cycle, which included isolating and labeling affected batches, re-inspecting batches, analyzing root causes, and preparing technical reports, all in close collaboration with the production, engineering, and quality teams, in order to prevent product leaks and ensure compliance with quality requirements.

-Responsible for reviewing and controlling standard operating procedures (SOPs), ensuring full compliance with regulatory standards and the complete absence of documentation deviations. Through change management on the quality management system (QMS) platforms, I was responsible for managing the change approval cycle, which involved managing approvals, reviews, and the closure of changes in accordance with the quality department’s standardized procedures.

-I used Statistical Process Control (SPC), historical process data analysis, and Minitab to reduce process variability; this initiative improved operational efficiency and ensured more consistent quality.

-I validated critical quality parameters in inspection matrices against technical specifications in engineering drawings to ensure design conformity and regulatory compliance of components, thereby mitigating the risk of deviations in later stages of production.

Prysmian Group | Process Engineering Analyst | 2023

-I standardized manufacturing operations by developing and updating standard operating procedures (SOPs) in line with technical production analysis, workplace safety requirements, and manufacturing engineering. This initiative ensured that processes complied with Good Manufacturing Practices (GMP) and optimized operations.

-I drove operational efficiency and productivity using Kaizen, Gemba Walks, 5S, and RCA methodologies, identifying process inefficiencies and optimizing workflow in the production area in collaboration with the production and engineering teams.

-I monitored machine downtime for the production of electrical conductors at the plant, identifying critical bottlenecks and providing useful data to the engineering department, which ensured the efficient fulfillment of production targets and the meeting of demand objectives within the organization.

Licenciatura en Ingeniería Química | Universidad de Costa Rica (UCR).