Antonio Gonzalez

About Antonio Gonzalez

Quality Engineering Management professional with full understanding of the requirements forType I and Type II medical device manufacturing.• Knowledge on the ISO 13485 standard and US regulations per the CFR §210, §211 and §820 andMedical Device Directive.• Risk management experience per requirements established in the standard ISO 14971.• Proficient in CAPA analysis and implementation, root cause identification, eliminationand verification.• Test equipment, Product and Hosted Services Software Validation management andimplementation• Design control cycle experience: Design inputs, Design outputs, Design verification, Designvalidation and Design transfer.• Knowledgeable of Biological test requirements for medical devices according to ISO standard 10993.• Knowledgeable on packaging requirements for sterile devices.• Knowledgeable of the stability requirements for drugs and cosmetics according to the EuropeanRegulations and FDA.• Validation and implementation of sterilization processes using Gamma irradiation and EO.• Minitab proficient. SAS user.• Proficient in using statistical techniques to identify variation causes during every stage of theproductive process, including gauge R&R studies and process capability analysis.• Proficient in the use of statistical comparison tools to identify differences in statisticalpopulations including ANOVA and t-tests.• Proficient in the use of linear models to predict expected outcomes from independent variables.

Experience

1. Senior Quality Engineering Manager

   SHL Medical

   Nov 2025 — Present · Charleston, SC, US

   Lead the Quality Engineering function at SHL’s new North Charleston site, overseeing validation, automation, and injection molding processes. My role focuses on building a defined quality strategy to drive effective technology transfers, ensure end to end process validation, and partner closely with cross functional teams to bring new products and manufacturing lines into commercial production. Responsible for aligning site quality objectives with SHL’s global standards, resolving quality issues, and cultivating a high-performing quality culture that supports operational growth.

Education

• Instituto Tecnológico de La Laguna

  Engineering, Electronics

  1990 — 1995

Skills

• Design of Experiments
• Manufacturing
• Iso 13485
• Plastic Extrusion
• Supplier Quality
• Extrusion
• Plastics Compounding
• Design Control
• Engineering
• Medical Devices
• Capa
• Fmea
• Manufacturing Engineering
• Business Process Improvement
• Fda
• Bioburden
• Plastics
• Validation
• Sterilization
• Process Improvement
• Quality System
• V&V
• Quality Management
• Root Cause Analysis
• Six Sigma
• Quality Auditing
• Minitab
• Lean Manufacturing
• Quality Control
• Gmp
• Injection Molding
• Quality Assurance
• Spc
• Continuous Improvement