YESSICA GUADALUPE Gómez López
Tijuana,Baja California
Summary
Adaptable Quality Engineer with 5+ years of experience in medical and appliance manufacturing, ensuring the quality of our processes to deliver products that meet all regulatory standards, prioritizing the safety and satisfaction of our customer. Passionate about compliance and developing the people in my charge, refining my leadership and people management skills.
Overview
8
8
years of professional experience
Work History
Process Quality Engineer
Hussmann Refrigeration
Tijuana, B.C.
08.2022 - Current
- Developed documentation, instructions, and specifications to meet product and client requirements and regulatory standards.
- Led root cause analyses to identify and address problems in production shop floor with A3 methodology, One Pager, 5G, and others, in collaboration with multidisciplinary team.
- Standardized quality inspections and create methods to validate and verify processes.
- Provided technical assistance to production team when issues arose.
- Developed and maintained quality documentation, conducted audit processes as LPA and maintaining regulatory compliance.
- Implemented Lean Six Sigma methodologies for continuous improvement of process quality and reduced COPQ target. Green Belt projects.
- Audit of internal processes to ensure compliance with ISO 9001, UL, CSA, WQA, Intertek and NSF requirements and drive continuous improvement efforts, as well as follow-up on non-conformities through CAPA's, A3, D8 and others.
- Collaborated with cross-functional teams to develop and implement quality control plans, PPAP, PFMEA, CTQ, Stage-gate/APQP, ensuring product consistency and quality.
- Managed third-party contractors, inspecting completed work and ongoing efforts to confirm quality and adherence to prescribed guidelines.
- Coached newly hired employees and interns while observing progress and delegating tasks.
- Trained operators on proper use of equipment and adherence to quality standards, reducing defects and rework.
- Reviewed tech field service to manage and analyze warranties from clients and improve our ICQ target (internal) with projects and sustain our quality indicator with our clients.
- Led second-part audits from clients and follow no conformities to close on time.
- Provide sustaining with technical service field if required, such as technical, documented or regulatory assistance.
- Manage team of quality inspectors and develop them, as auditors or quality technicians.
Quality Lead
Stryker
Tijuana, B.C.
06.2016 - 06.2022
- Staff management, leading group of 15 quality inspector in two sites.
- Follow-up and reviewed procedures from ISO 13485 in production shop floor, conducting audit process as LPA.
- Staff training in procedures of QMS
- Sampling plans' execution.
- Destructive test based on sampling plans (AQL according to production schedule)
- Support destructive test for validation processes
- Generation and follow-up NC/CAPA related to internal rejections based on quality specifications and QMS procedures
- Control and verification of DHR, managed throughout good manufacturing practices (GMP)
- Sustaining in production shop floor when issues arose.
- Closing of Work Orders in MES and SAP
- Documented nonconforming material and reported to appropriate team leaders for review and assessment.
- Recorded and organized test data for report generation and analysis.
- Performed tests and inspections to conform to established standards in Quality Line, Quality Outgoing and Incoming Inspection.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Collaborated with cross-functional teams to address root causes of quality issues, resulting in improved processes and products.
- Maintained service records, coordinated repairs and oversaw preventive maintenance of manufacturing equipment.
Education
Associate of Applied Science - Industrial Engineering
Universidad De Tijuana CUT
Tijuana04.2022
Skills
- Root Cause Analysis
- Statistical Data Analysis
- Cross-Functional Teamwork
- Quality Training Delivery
- Documents and reports
- New Process Implementation
- ISO 9001 Knowledge
- Quality Risk Assessment
- KPI Monitoring
Timeline
Process Quality Engineer
Hussmann Refrigeration
08.2022 - Current
Quality Lead
Stryker
06.2016 - 06.2022
Associate of Applied Science - Industrial Engineering
Universidad De Tijuana CUT