Kaína Quirós Vega
San Ramon
Summary
Strategic and empathetic Quality Enginner with a strong orientation toward continuous improvement, workplace well-being, and organizational excellence. With a solid foundation in Lean methodologies and Kaizen principles. Known for my analytical mindset, emotional intelligence, and ability to foster collaborative environments that drive sustainable results. Passionate about aligning quality standards with human-centered processes to enhance performance and engagement across teams.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Engineer
Steris AST EO
12.2021 - Current
- Leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles.
- Executes activities concerned with the development, implementation, maintenance, and continuous improvement of quality systems.
- Supports production operations by coordinating and performing problem-solving investigations, pre-reviews and final acceptance/run release of processing runs that contain non-conformances.
- Responsible for the activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications including calibrations, generation of test methods, audits, scheduling, validations, record keeping and reporting.
- Responsible for executing product and/or report releases for all processing runs/lab samples containing a non-conformance, including management of Customer communication and leading the associated non-conformance investigations.
- Perform internal audits at other AST facilities, including identification of non-compliances and report generation. Responsible for managing remediation of internal audit
observations. - Review collected data to perform statistical analysis and recommend process changes to improve quality.
- Collaborate with other departments and facilities within the company on quality related issues.
- Lead quality system programs (i.e. calibration, maintenance, training, CAPA, complaints, non-conformances, supplier quality, management review, operational qualifications, document control, change control, risk management, etc).
Process Engineer
Laboratorios Stein S.A
01.2021 - 12.2021
- Led process optimization initiatives, enhancing production efficiency and reducing waste.
- Developed and implemented standard operating procedures for manufacturing processes.
- Application of the 5’s principles into Kanban of supplies to reduce time of execution of the workloads.
- Managed project timelines effectively, ensuring timely completion of engineering projects.
- Optimized manufacturing processes by implementing continuous improvement initiatives and lean methodologies.
- Championed and facilitated kaizen events to drive continuous improvement efforts throughout the organization, resulting in a culture of operational excellence.
Validation Analyst Intern
Laboratorios Stein S.A
01.2020 - 12.2020
- Development of proposal for the definition and standardization of the critical parameters of the process to obtain the CQA within specification limits using DOE.
- Application of the proper statistical methods for the adequate sample size, stability and process capacity.
- Developed and implemented validation plans for manufacturing processes and equipment.
- Enhanced product quality through testing and data analysis of manufacturing processes.
- Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments.
Education
Bachelor's degree - Industrial Production Engineering
Costa Rica Institute of Technology
Cartago, Costa Rica10.2020
Skills
- Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objective
- Solid problem-solving, organizational, analytical and critical thinking skills
- Adaptable, flexible and with rapid knowledge
- Effective teamwork integration
- Interpersonal skills
- Leadership and organized
- Able to orchestrate multiple activities at once under limited direction
- Critical thinking
Certification
- Minitab Quality trainer | 2019
- Design of experiments applied to pharmaceutical, cosmetic and food industries Pharmaceutical Services and Consulting | May 2021-Jun 2021
- Lean Toolbox for Services PXS School of Excellence | Mar 2022-Jun 2022
LANGUAGES
Spanish: Native speaker
English: Intermediate (B2)
Timeline
Quality Engineer
Steris AST EO
12.2021 - Current
Process Engineer
Laboratorios Stein S.A
01.2021 - 12.2021
Validation Analyst Intern
Laboratorios Stein S.A
01.2020 - 12.2020
Bachelor's degree - Industrial Production Engineering
Costa Rica Institute of Technology
Similar Profiles
Alyssa EotvosAlyssa Eotvos
Laboratory Technician II at STERIS ASTLaboratory Technician II at STERIS AST
Gary Christian LayugGary Christian Layug
Material Handler 2 at Steris ASTMaterial Handler 2 at Steris AST
Amanda StaleyAmanda Staley
Supervisor, Quality at STERIS ASTSupervisor, Quality at STERIS AST
David JacobsDavid Jacobs
Service Advisor/Manager at Esuropean AutotechService Advisor/Manager at Esuropean Autotech
Gokul Selvam SadasivamGokul Selvam Sadasivam
Sr. Manager - Commissions & Legal Systems at Okta IncSr. Manager - Commissions & Legal Systems at Okta Inc