Summary
Overview
Work History
Education
Skills
Timeline
Generic

Leidy Karina Cepeda Olaya

Orlando,FL

Summary

Accomplished Quality Engineer with a proven track record at BIOMEG, enhancing operational efficiency through strategic planning and process optimization. Expert in ISO 9001:2015 audits and Quality Management Systems, I excel in cross-functional team collaboration and resource management, significantly improving quality metrics and incident resolution.

Overview

16
16
years of professional experience

Work History

Quality Engineer

BIOMEG
02.2018 - Current
  • Establish detailed quality guidelines and verified process fulfillment in accordance with technical and maintenance requirements
  • Implemented and maintained the Quality Management System (QMS) with a focus on incident resolution and continuous improvement
  • Conducted audits according to ISO 9001:2015 standards, ensuring compliance and quality metrics alignment
  • Supervised production cycles, performed periodic tests, and identified potential failures proactively, improving operational efficiency

Laboratory Technical Director

Tecnoclinica Ltda
09.2011 - 03.2018
  • Oversaw technical operations and ensured resource availability to maintain laboratory quality standards
  • Developed technical strategies to meet quality objectives and manage resource planning
  • Coordinated calibration procedures and implemented laboratory management systems

Head of Maintenance and General Services

Santiago de Cali Clinic
09.2010 - 08.2011
  • Directed maintenance, biomedical engineering, and general services areas
  • Managed personnel, coordinated training, and ensured compliance with occupational health and safety regulations
  • Oversaw biomedical equipment maintenance and warranty management

Bioelectronic Engineering

Sysmed
03.2010 - 07.2010
  • Preventive and corrective maintenance of biomedical equipment, taking advantage of the institution's maintenance plan
  • Collection of biomedical equipment resumes technical data sheets and maintenance history of the institution's biomedical equipment
  • Train healthcare area personnel for the correct use of biomedical equipment

Maintenance Manager

Hospital Departamental de Buenaventura
06.2009 - 10.2009
  • Performed preventive and corrective maintenance of biomedical equipment
  • Collected technical data and maintenance history for biomedical equipment
  • Trained healthcare personnel and provided technical advice on acquiring and modernizing equipment

Education

Biomedical Engineer (Bachelor Degree) -

Universidad Autónoma De Occidente
06-2008

Auditor Interno -

Pontificia Universidad Javeriana Cali
01.2025

Diploma - Gestión en Laboratorio de ensayo y/o calibración norma NTC/ISO 17025:2005

Pontificia Universidad Javeriana Cali
01.2015

Gestión de calidad y aseguramiento metrológico en equipos médicos -

Universidad Autónoma de Occidente
01.2010

Skills

  • Strategic Planning
  • Process Optimization
  • Operational Supervision
  • Resource Management
  • Cross-functional team collaboration

Timeline

Quality Engineer

BIOMEG
02.2018 - Current

Laboratory Technical Director

Tecnoclinica Ltda
09.2011 - 03.2018

Head of Maintenance and General Services

Santiago de Cali Clinic
09.2010 - 08.2011

Bioelectronic Engineering

Sysmed
03.2010 - 07.2010

Maintenance Manager

Hospital Departamental de Buenaventura
06.2009 - 10.2009

Biomedical Engineer (Bachelor Degree) -

Universidad Autónoma De Occidente

Auditor Interno -

Pontificia Universidad Javeriana Cali

Diploma - Gestión en Laboratorio de ensayo y/o calibración norma NTC/ISO 17025:2005

Pontificia Universidad Javeriana Cali

Gestión de calidad y aseguramiento metrológico en equipos médicos -

Universidad Autónoma de Occidente
Leidy Karina Cepeda Olaya