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
9
9
years of professional experience
Work History
Quality Complaints Engineer
Ossur Americas
Tijuana, Baja California, Mexico
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
Tijuana, Baja California, Mexico
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
Tijuana, Baja California, Mexico
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
Tijuana, Baja California, Mexico
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
Tijuana, Baja California, Mexico
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
Education
Certificate Program in Six Sigma Green Belt -
CETYS Universidad
Tijuana, Baja California, Mexico12-2024
Course - Rapid Problem Solving
Lean Sigma Academy
Tijuana, Baja California, Mexico10-2024
Course - Process Validation For The Medical Industry
Lean Sigma Academy
Tijuana, Baja California, Mexico09-2024
Course - Failure Mode And Effects Analysis
Lean Sigma Academy
Tijuana, Baja California, Mexico09-2024
Degree - Industrial Engineering
Universidad De Tijuana CUT
Tijuana, Baja California, Mexico08-2021
Skills
- Failure analysis
- Critical thinking
- Project management
- Data analysis
- Technical reporting
- Lean manufacturing tools
- Corrective and preventive actions
- Customer service
- Quality documentation
- Risk management
Languages
English
Advanced (C1)
Spanish
Bilingual or Proficient (C2)
Software
- Minitab
- Power Bi
- Microsoft Project
- Microsoft Planner
- ETQ
- Sap
- Navition
- Solidworks
- Outlook
- Micosoft Office
- AutoCad
- Vizio
Timeline
Quality Complaints Engineer
Ossur Americas
03.2021 - Current
Junior Manufacturing Engineer
Ossur Americas
04.2019 - 03.2021
Quality Control Team Leader
Demant
08.2017 - 04.2019
Quality Control Inspector
Demant
12.2016 - 08.2017
Quality Control Inspector
Jabil
05.2016 - 11.2016
Certificate Program in Six Sigma Green Belt -
CETYS Universidad
Course - Rapid Problem Solving
Lean Sigma Academy
Course - Process Validation For The Medical Industry
Lean Sigma Academy
Course - Failure Mode And Effects Analysis
Lean Sigma Academy
Degree - Industrial Engineering
Universidad De Tijuana CUT