Jorge Alejandro Gonzalez Hernandez

Tijuana,BCN

Summary

Quality Complaints Engineer with over 8 years of experience in the medical manufacturing industry, specializing in product complaint investigations for hearing devices and knee prostheses. Expert in root cause analysis, functional testing, and collaborating with cross-functional teams to drive quality improvements and regulatory compliance. Holds a Six Sigma Green Belt Diploma from CETYS Universidad, demonstrating a strong foundation in process optimization and quality management. Starting a Master's in Engineering and Innovation with a Specialization in Semiconductors at CETYS Universidad in January 2025 to expand expertise in cutting-edge manufacturing and innovation.

Overview

years of professional experience

Work History

Quality Complaints Engineer

Ossur Americas

03.2021 - Current

Customer Complaint Resolution: Managed and resolved complaints and incidents related to hydraulic and mechanical knee prostheses across seven models, ensuring customer satisfaction and safety.
Root Cause Analysis: Applied advanced quality methodologies such as RCA, 5 Why's, Pareto Diagrams, FTA, FMEA, and flowcharts to identify and address failure causes effectively.
Detailed Investigations: Conducted comprehensive root cause investigations for the Global Quality Center in Iceland, including analysis of manufacturing documentation, component batches, test data, service history, incident details, and customer information.
Incident Reporting: Prepared and submitted Injury Reports and root cause reports for incidents involving knee prostheses, leveraging historical product investigations to ensure regulatory compliance and quality improvement.
Failure Reporting: Delivered detailed failure analysis reports to design, manufacturing, and engineering teams, providing actionable insights for product and process improvements.
Product and Data Oversight: Administered databases for complaints, credits, incidents, warranties, and loans, maintaining accuracy and facilitating data-driven decision-making.
Cross-Functional Collaboration: Worked closely with Customer Service, Engineering, Production, Regulatory Affairs, and Design teams to resolve product issues and implement corrective and preventive actions.
Training and Development: Conducted training sessions for service personnel, ensuring proficiency in handling and testing medical devices.
Product Testing: Supervised and conducted functional and tests such as Spring Test, Friction Test, M/L Test, and Cycle Test to ensure product reliability and quality.

Junior Manufacturing Engineer

Ossur Americas

04.2019 - 03.2021

Participated in the transfer of seven different transfemoral knee prostheses from Michigan, U.S., to Tijuana.
Developed layouts for production lines and cells.
Translated work instructions from English to Spanish.
Created work instructions and developed technical documentation, including Standard Operating Procedures (SOPs), manuals, and engineering drawings to support manufacturing operations.
Followed up on NCs (Non-Conformities).
Supported the Manufacturing Engineer in validations (IQ, OQ, and PQ).
Trained operational staff.
Performed time studies and balanced production lines.
Created Bills of Materials (BOM).
Developed a database for tools, machines, and measurement equipment.
Improved manufacturing efficiency by streamlining production processes and implementing lean methodologies.
Reduced production downtime through proactive maintenance scheduling and timely equipment repairs.
Increased capacity utilization by identifying bottlenecks in the production process and implementing targeted improvements.

Quality Control Team Leader

Demant

08.2017 - 04.2019

Providing support during MDSAP, ISO 13485, and COFEPRIS audits.
Supervising 10 quality inspectors.
Coordinating the quality inspection team to perform dimensional, functional, and visual tests in the manufacturing process, finished products, and validations of hearing devices.
Overseeing inspections of new hearing devices, as well as service and repair inspections.
Supervising inspections of hearing devices from various brands, including Bernafon, Sonic, and Oticon.
Supervising the programming of hearing devices in Genie for U.S. war veterans.
Conducting training sessions on ear anatomy for inspectors.
Delivering reports and metrics to production and quality management teams.
Following up on customer complaints through preventive and corrective actions.
Managing the calibration and quality systems.
Training quality inspectors.
Creating new visual aids.

Quality Control Inspector

Demant

12.2016 - 08.2017

Conducted visual, dimensional, and functional inspections of hearing aids, including Wireless, Bluetooth, T-coil, and NFMI technologies.
Performed ATS (Acoustic Test Sound) tests to ensure quality and functionality.
Conducted listening tests and AutoPhone tests for device validation.
Reviewed acoustic tests for hearing aids across three different product families.
Programmed hearing aids using Genie software for U.S. war veterans, ensuring device accuracy and reliability.
Performed process inspections to maintain quality standards throughout manufacturing.
Audited production lines to ensure compliance with quality protocols and standards.
Inspected and verified documentation of hearing aids for accuracy and completeness.
Analyzed and reviewed electronic components of hearing aids using the CATHIA program.

Quality Control Inspector

Jabil

05.2016 - 11.2016

Conducting functional and destructive tests.
Performing pull tests, leak tests, and flow tests.
Carrying out dimensional testing.
Conducting dimensional, visual, and packaging inspections during the manufacturing process, finished products, and validations (OQ, PQ).
Verifying RF machine parameters.
Documenting DHR (Device History Record) completion, lot assignments, and first article inspections.
Performing line clearance verification.
Ensuring compliance with 5S and Personal Protective Equipment (PPE) standards on production lines.
Verifying calibration systems.
Auditing production lines