Hernan Ruiz

Background

About Hernan Ruiz

With over 15 years of work experience, I am a passionate and driven Quality Manager with a Master of Business Administration degree. I have extensive knowledge and skills in technical production, medical device manufacturing, and P&L management. I worked at Establishment Labs, a global medical technology company that designs, develops, and manufactures innovative breast implants and aesthetic products. I am committed to delivering high-quality products that meet the needs and expectations of our customers and stakeholders, and to fostering a culture of excellence, innovation, and continuous improvement within our organization. In my last role, I was responsible for managing the Quality Technical Services department, which includes the Incoming, Metrology, and Microbiology labs. I oversee the quality control, inspection, testing, and verification of raw materials, components, finished products, and environmental conditions. I also ensure compliance with the regulatory requirements and standards of the medical device industry, such as ISO 13485, FDA 21 CFR Part 820, and MDSAP. I work closely with the production, engineering, and supply chain teams to optimize the manufacturing processes, reduce costs, and improve efficiency and productivity. I have successfully implemented multiple quality improvement projects, such as the automation of the metrology lab, the validation of the microbiology lab, and the optimization of the incoming inspection process. I have also led and trained a team of skilled and motivated quality technicians and analysts, who have consistently achieved high performance and customer satisfaction ratings.