Amalbert

About Amalbert

Have you ever delivered Director-level results with a Manager title?Me too. For over 24 years.I\'m a Puerto Rican engineer, BSEE from UPR Mayagüez and MBA, who built a career in some of the most regulated environments in the world: medical devices, combination products, pharma, aerospace. Class PMA. FDA. EU MDR. The kind of work where there is no margin for error.What I do: I build Supplier Quality & Compliance organizations from zero. I architect governance frameworks that make companies audit-ready and inspection-proof. I lead teams. I partner with VPs. I de-risk $50M+ commercial launches and clinical programs, and I do it while the title on my badge says something that doesn\'t match the scope of the work.That gap between what you do and what you\'re called? I know it intimately.I\'ve reduced SCAR closure timelines from 2 years to under 180 days. Reduced supplier nonconformance resolution from 2 years to under 60 days. Achieved zero findings in Notified Body audits. Built teams from zero to functional in 6 months. Been recognized by VPs at Medtronic, Pfizer, and Cordis for delivering results that moved the needle.And in parallel, I wrote about it.Jíbara en la Luna and Nietos en la Diáspora are my books. The lessons Corporate America never puts in the training manual, about navigating systems that weren\'t built for us, recognizing your value before the exit interview, and building what\'s next on your own terms. I coach Latina professionals in STEM who are done being underestimated.Two careers. One story.The engineer who never stopped building. The author who documented every lesson along the way. Irvine, CA | Open to Director-level opportunities in medical devices & combination products Books in English & Spanish · jibaroenlaluna.com Speaking · Corporate workshops · 1:1 strategic coaching

Experience

1. Senior Manager, Supplier Quality

   Cordis

   Mar 2026 — Present · Ирвайн, CA, US

   Leading supplier quality strategy for MedAlliance in cross-organizational collaboration with the Cordis team, with direct representation at VP and Sr. Director levels across R&D, Regulatory, and Operations.Driving regulatory compliance for Clinical Suppliers and Selution program at Miami Lakes, applying ISO 9001 and FDA 21 CFR Part 820 frameworks.Operating at Director-level scope, delegated to represent MedAlliance in strategic programs across both organizations.

Education

• University of Puerto Rico-Mayaguez

  Bachelor of Science (BS), Electrical and Electronics Engineering

  1996 — 2001

• University of Phoenix

  MBA, Human Resources

  2005 — 2007