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
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