"The current regulatory framework requires not only a best-in-class product but a methodical approach to continuously improve quality at all levels,”
New York, NY (PRWEB) May 26, 2017
Establishment Labs, a global medical device company focused on aesthetic technologies with a strong emphasis on product development and innovation, announced today the expansion of its leadership team with the addition of Alberto Quesada as Vice President of Quality Assurance & Regulatory Affairs.
“We are pleased to add a senior executive with Alberto’s deep expertise during this exciting stage of our growth. His background and track record of achievement within high-profile healthcare companies, such as Boston Scientific and Allergan, will add great value as we expand,” said Juan José Chacón-Quirós, CEO and founder of Establishment Labs.
“Alberto’s drive for organizational excellence and standard of quality aligns perfectly with our goal of becoming a global leader in aesthetic and reconstructive devices technology, while improving patient safety through product innovation."
Alberto Quesada brings more than two decades of experience in quality assurance, quality control, and regulatory affairs to Establishment Labs. He will lead all activities related to the design, manufacture and distribution of quality products with the highest industry standard, as well as compliance with the company’s Quality Management System and applicable regulations. In addition, Mr. Quesada will lead all regulatory aspects of the business to support appropriate and timely introduction of products as well as a continuous state of compliance with markets’ regulatory requirements.
"The current regulatory framework requires not only a best-in-class product but a methodical approach to continuously improve quality at all levels,” stated Mr. Quesada. “Our plan is to deepen our competitive advantages by building a stronger set of capabilities in our Quality Management System."
Prior to joining Establishment Labs, Mr. Quesada served as a Quality Director and later as a Management Representative at Boston Scientific in Costa Rica. Previously, he spent nearly a decade with Allergan Corporation, where he served in senior quality management roles. He also held roles at Baxter Healthcare Corporation, Kativo Chemical Industries and GTE Sylvania. Mr. Quesada received his MBA from Universidad Estatal a Distancia (UNED), Costa Rica and his undergraduate degree in Industrial Engineering from the University of Costa Rica.
About Establishment Labs
Establishment Labs is a global, privately held, medical technology company with a strong emphasis on innovation that designs, develops, manufactures and markets an innovative product portfolio. Its CE-marked Motiva Implants® line of silicone breast implants (http://www.motivaimplants.com) utilizes ultra-high purity medical-grade silicone and is subject to the strictest quality assurance testing throughout the manufacturing process. Motiva Implants® are sold in more than 60 countries worldwide. Puregraft®'s FDA cleared and CE-Marked technology provides plastic surgeons with purified fat for reinjection on the sterile field and is used in hospitals and clinics around the world. Divina® is a proprietary 3D imaging technology for full integration in consultation and surgical planning of unique solutions for breast aesthetics and reconstruction. All manufacturing facilities are fully compliant with both FDA and ISO applicable standards.