Karely Guadalupe Rios Avila
Tijuana
Summary
Dedicated and adaptable professional with a proactive attitude and the ability to learn quickly. Strong work ethic and effective communication skills. Eager to contribute to a dynamic team and support organizational goals.
Overview
3
3
years of professional experience
Work History
Process Quality Engineer
Medtronic Mexico
Tijuana
02.2023 - Current
- Reviewed design drawings prior to fabrication or assembly of parts and components to confirm accuracy according to customer specifications.
- Ensured that all personnel involved in the manufacture or testing of products are adequately trained in relevant areas such as safety, health, environmental protection.
- Coordinated calibration activities for measuring instruments used during inspections, tests as per ISO 9001, ISO 14001 standards.
- Created reports detailing the results of inspections, tests and evaluations.
- Implemented changes to production methods in order to improve the overall efficiency of manufacturing operations.
- Maintained accurate records of all inspection activities according to company policies and regulatory guidelines.
- Developed strategies for continuous improvement in product reliability by identifying potential failure modes through risk assessment techniques.
- Monitored incoming materials to verify conformance with specified requirements.
- Identified opportunities for process improvement initiatives based on data collected from quality control operations.
- Developed and maintained quality assurance standards for production processes.
- Designed test plans, protocols and procedures for evaluating product performance against established criteria.
- Investigated supplier discrepancies, evaluated corrective action plans and monitored implementation progress.
- Provided technical guidance in resolving complex problems associated with non-conforming parts or components.
- Investigated customer complaints related to product quality issues and developed solutions to prevent recurrence.
- Performed root cause analysis on defective products to identify sources of errors and recommend corrective actions.
- Analyzed product specifications, customer requirements and industry regulations to determine appropriate quality assurance processes.
- Collaborated closely with other departments such as engineering, procurement, sales to ensure consistent adherence to quality standards across the organization.
- Conducted regular audits of production processes to ensure compliance with established standards.
- Documented all findings from quality control activities including inspection results, audit observations and test data.
- Defined equipment and parts from external suppliers.
- Analyzed project requirements and performed technical calculations supporting design solutions.
- Kept engineering designs in conformance with safety objectives and legal requirements to minimize issues.
- Created customer documentation such as diagrams, electrical drawings and manuals.
- Oversaw project workflow and supported internal and external resources.
- Prepared reports detailing data analysis along with prospective solutions, benefits and costs.
- Developed and tested models of alternate designs or processing methods to assess feasibility.
- Researched, designed and installed mechanical products or equipment to meet requirements.
- Assessed operations and made key suggestions to implement more cost-effective processes and lean manufacturing principles.
- Wrote performance requirements for product development or engineering projects.
- Developed and implemented best practices, quality assurance standards and project management procedures.
- Estimated costs or submitted bids for engineering, construction or extraction projects.
- Applied comprehensive set of industrial engineering techniques including statistics and simulation to solve highly complex business analysis.
- Specified system components or direct product modifications to verify conformance with engineering design or performance specifications.
- Created and maintained process and production documentation.
NPI Quality Engineer
Medtronic Mexico
Tijuana
09.2022 - 01.2023
- Monitored compliance with established standards and procedures related to validation activities.
- Validated software applications related to manufacturing operations.
- Prepared traceability matrices to ensure traceability of system components.
- Reviewed engineering drawings and specifications for accuracy in validation documentation.
- Participated in cross-functional teams to develop validation strategies.
- Verified that all systems were functioning according to design parameters through testing and inspection.
- Created detailed reports documenting results from validations activities.
- Authored and executed qualification protocols for clean utilities, HVAC, and manufacturing processes.
- Compiled summary reports from previous validations to use as reference material for future projects.
- Assisted with the development of user requirement specifications.
- Identified areas where process improvements could be implemented based on validation data collected during execution phase.
- Resolved any issues that arose during the course of validations by troubleshooting problems as they occurred.
- Performed risk assessments on new processes and equipment.
- Ensured proper implementation of change control procedures when needed.
- Led training sessions on best practices for executing validation activities.
- Developed validation protocols for process equipment and systems.
- Analyzed data to ensure compliance with FDA regulations.
- Provided technical support in the development of test plans, protocols, reports, SOPs.
- Maintained accurate records of all tests performed throughout the entire life cycle of a product or system.
- Inspected, calibrated and tested instruments used to manufacture medical devices.
- Investigated equipment failures, identified causes and initiated methods to resolve such issues.
- Documented entire validation process and recorded all changes.
- Provided high level of training to professionals, thoroughly explaining validation methods and testing procedures.
- Presented complex technical data in easily understood terms to individuals without engineering backgrounds.
- Identified safety issues and performance trends by performing statistical analysis.
- Suggested updates to software to improve usability, function, and performance of products.
- Provided continuous process improvement and preventive and corrective actions to facilitate operational efficiency.
- Managed supplier key performance indicators and checked materials for compliance with specifications.
- Implemented OSHA compliance quality and safety plans.
- Collaborated with production team members to help team create and deliver high quality, cutting-edge products.
- Communicated effectively with customers and contractors to facilitate business operations.
- Scheduled validation testing with different departments and managers.
- Collected samples to validate against parameters using various approved tests.
- Provided clear and concise cost and time estimates for each phase of testing from test phase planning to final regression testing.
- Maintained and calibrated testing equipment to consistently produce reliable results.
- Developed protocols for validating products against internal and industry standards.
Quality Laboratory Undergrad Intern
Medtronic Mexico
Tijuana
01.2022 - 08.2022
- Maintained accurate records of all activities performed throughout internship period.
- Prepared reports summarizing project progress and results for management review.
- Assisted with event planning, support and execution of virtual and in-person engagements.
- Helped maintain applicant tracking systems and recruiting metrics.
- Set specific goals for projects to measure progress and evaluate end results.
- Analyzed key performance indicators to identify effective strategies.
- Wrote and submitted reports on industry trends, prompting managers to develop business plans.
- Tracked project schedules and encouraged teams to complete tasks on time while staying on budget.
- Evaluated needs of departments and delegated tasks to optimize overall production.
- Audited company's legal documents to verify compliant policies and procedures.
- Identified areas for improvement, narrowing focus for decision-makers in making necessary changes.
- Worked closely with human resources to support employee management and organizational planning.
- Determined consumer needs to provide products and services appealing to larger market.
- Utilized document management system to organize company files, keeping up-to-date and easily accessible data.
- Implemented strategies to take advantage of new opportunities.
- Monitored operations and reviewed records and metrics to understand company performance.
- Created plans to propose solutions to problems related to efficiency, costs or profits.
- Assessed company operations for compliance with safety standards.
- Oversaw quality control to identify inconsistencies and malfunctions.
- Developed new techniques for isolating organisms from complex mixtures.
- Processed biological samples according to established procedures with attention to detail.
- Ordered necessary chemicals, reagents, media components, glassware items as needed.
- Provided technical assistance to scientists during experiments or research projects.
- Performed basic molecular biology techniques such as PCR amplification.
- Maintained a clean work environment by following safety protocols and guidelines.
- Recorded test data accurately in laboratory notebooks or computer databases.
- Assisted in the development of new methods and protocols for testing specimens.
- Troubleshot any problems that occurred with instruments or procedures in the lab.
- Monitored cultures for growth and analyzed results using microscopes and other lab tools.
- Disposed hazardous materials according to proper protocols.
- Operated centrifuges, pipettes, autoclaves, vortexers, incubators, and other laboratory equipment.
- Analyzed microbial cultures for antibiotic sensitivity tests.
- Cultivated bacterial strains from clinical specimens or environmental sources.
- Performed quality control checks on equipment, instruments, supplies, and reagents.
- Organized inventory of supplies and equipment in the laboratory setting.
- Maintained accurate records of test results in accordance with regulatory standards.
- Conducted laboratory tests on samples to analyze the presence of bacteria and other microorganisms.
- Prepared media and reagents for various microbiological experiments.
- Performed, validated and reported laboratory tests for prognosis, diagnosis, treatment, and research.
- Followed laboratory guidelines for handling biological specimens.
- Tested raw materials to determine quality and characteristics of substance.
- Prepared standard solutions to combine with samples according to formulas or procedures.
- Validated laboratory test processes for completeness and safety.
- Recorded test or medical data for reports using narratives, charts or graphs.
- Collected tissue samples from bovine and porcine for lab work.
- Maintained and tested sterility of medical equipment.
- Combined reagents with samples following standardized experimental processes.
- Analyzed results of tests for conformity to specifications.
- Supervised or instructed new technicians on laboratory protocols.
- Inoculated bacteriological material with test organisms.
Education
Bachelor of Science - Biochemical Engineer
Instituto Tecnologico De Tijuana
Tijuana Baja CaliforniaSkills
- Process Monitoring
- Six Sigma methodology
- Process Validation
- Problem solving techniques
- Quality Management Systems
- Process Mapping
- Statistical process control
- Corrective Action Implementation
- Design validation
- Six Sigma Methodologies
- Chemical engineering
- Cost-reduction strategies
- Statistical Data Analysis
- Communication
- Teamwork
- Time management
- Languages: Spanish, English
- Software: Microsoft Office, Super Pro Designer, UVProbe, AutoCAD, Minitab, SAP, Agile MAP, LIMS
Timeline
Process Quality Engineer
Medtronic Mexico
02.2023 - Current
NPI Quality Engineer
Medtronic Mexico
09.2022 - 01.2023
Quality Laboratory Undergrad Intern
Medtronic Mexico
01.2022 - 08.2022
Bachelor of Science - Biochemical Engineer
Instituto Tecnologico De Tijuana
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