Ramon Quirantes is a dedicated Quality Engineer at Goode Compliance International, where he leverages his extensive expertise in quality assurance and regulatory compliance within the medical device sector. With a strong focus on ensuring that products meet stringent FDA 21 CFR 820 and ISO 13485...
Ramon Quirantes is a dedicated Quality Engineer at Goode Compliance International, where he leverages his extensive expertise in quality assurance and regulatory compliance within the medical device sector. With a strong focus on ensuring that products meet stringent FDA 21 CFR 820 and ISO 13485 standards, Ramon plays a pivotal role in the entire lifecycle of medical devices—from product design and development to market release and post-market surveillance. His commitment to quality is evident in his meticulous approach to design control and process validation, ensuring that every product not only meets regulatory requirements but also exceeds customer expectations.
At Goode Compliance International, Ramon has spearheaded several key projects that have significantly enhanced operational efficiency. Notably, he trained team members on documentation templates, which streamlined processes and reduced cycle times, thereby improving overall productivity. His analytical skills are further demonstrated through his ability to track and report on individual and team metrics, providing valuable insights into cycle time, output, and coordination. This data-driven approach enables him to effectively plan project timelines and manage resources, ensuring that quality deadlines are consistently met.
Ramon's expertise extends to conducting detailed Failure Investigation Reports, where he meticulously analyzes product failures and implements corrective actions. His proficiency in tools such as FMEA and Poka Yoke, combined with his knowledge of GMP and ISO 14971, positions him as a key contributor to the continuous improvement of quality systems. With a strong foundation in regulatory affairs and a keen eye for detail, Ramon Quirantes is committed to advancing quality engineering practices within the medical device industry, ensuring that safety and efficacy remain at the forefront of product development.
