Luisana Sánchez
Tijuana
Summary
Dedicated engineer with +6 years of experience in the medical device industry, with expertise in developing, implementing, and maintaining Quality Management Systems, risk management, CAPA, and compliance with ISO and FDA regulations. Skilled in product and process validations, documentation management, design reviews, and manufacturing operations. Known for meticulous attention to detail and a strong commitment to quality and precision.
Overview
7
7
years of professional experience
Work History
QUALITY SYSTEMS ENGINEER
Precision Medical Products thru Lean Lead Consulting
Remote
02.2020 - Current
- Developed and maintained quality systems to ensure compliance with ISO 9001 and ISO 13485 standards.
- Generate appropriate documentation and assistance to support an FDA 510(k) approval
- Full participation in Risk Management activities; create a risk management plan, perform product risk assessment, develop the DFMEA and create the risk management report
- Assist in the identification, development and implementation of corrective and preventive actions (CAPA) to improve overall quality results
- Responsible for the creation and maintenance of design history files for assigned projects adhering to design control procedures
- Generate, control and maintain comprehensive documentation for all quality management system components, such as but not limited to design control documents, SOPs, label verifications, test protocols and reports
- Provide quality engineering support in New Product Design and Engineering Change projects to ensure compliance with ISO and FDA regulations
- Review audit reports, assess findings and suggest corrective or preventive actions.
VALIDATION ENGINEER
Fisher & Paykel Healthcare
Tijuana
01.2019 - 02.2020
- Plan, coordinate and execute process validations through the IQ, OQ & PQ phases when introducing or changing manufacturing processes or equipment
- Line transfer from NZ plant to MX plant of 7 different product models
- Generate validation documentation such as Master Validation Plan, Protocol, Validation Report, Test Report and Test Indecent Report
- Identified safety issues and performance trends by performing statistical analysis.
- Verified that all systems were functioning according to design parameters through testing and inspection.
- Responsible for ensuring the technical, economic, regulatory and product design viability, involving all relevant stakeholders.
MANUFACTURING ENGINEER
Fisher & Paykel Healthcare
Tijuana
11.2016 - 06.2017
- Overseeing the production of two product families that collectively contribute to 60% of the company's overall business.
- Developed and implemented manufacturing process improvement initiatives to increase efficiency and reduce downtime.
- Delivered technical support to troubleshoot equipment issues arising in the manufacturing process.
- Performed root cause analysis on various production issues and developed corrective actions plans.
- Responsible of the manufacturing Key Performance Indicators of the production lines and reporting them to Management Staff through weekly meetings, as well as actions and projects to maintain KPI's according to company's objectives
- Developed detailed documentation for all processes including Standard Operating Procedures.
- Participated in cross-functional teams responsible for developing innovative solutions that reduced costs or improved quality and delivery performance.
Education
Bachelor of Science in Industrial Engineering - Strategic Manufacturing Management
CETYS UNIVERSITY
01.2018
Skills
- Quality Management Systems
- Compliance with FDA and ISO Regulations
- 510(k) submission
- Risk Management
- DFMEA
- Quality Assurance
- Design Controls
- Project Management
- CAPA
- Corrective Action
- Product Development
- Process Validation
- MSOffice
- SAP Systems
- AutoCAD
Languages
- Spanish (Native)
- English (Fluent)
- German (Basic)
Timeline
QUALITY SYSTEMS ENGINEER
Precision Medical Products thru Lean Lead Consulting
02.2020 - Current
VALIDATION ENGINEER
Fisher & Paykel Healthcare
01.2019 - 02.2020
MANUFACTURING ENGINEER
Fisher & Paykel Healthcare
11.2016 - 06.2017
Bachelor of Science in Industrial Engineering - Strategic Manufacturing Management
CETYS UNIVERSITY
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