Alejandro Moronta

Background

About Alejandro Moronta

As a business enabler and operations professional, I specialize in optimizing processes to drive efficiency and ensure satisfaction for both internal and external customers. I am an expert in management systems with a strong emphasis on quality, risk, compliance, and regulatory environments (ISO 9001, ISO 13485, FDA), leveraging advanced data analytics and Six Sigma methodologies to identify root causes and implement lasting solutions. My results-driven approach is rooted in the accurate identification of potential and current challenges, removing obstacles to achieve strategic goals. I am a trusted agent of change, deeply engaged in cultural transformation, stakeholder management, and coaching and mentoring team members. My ability to foster stable, motivating work environments helps organizations cultivate trust and long-term success. Professional qualifications include: •Certified Quality Engineer (CQE) •Certified Quality Auditor (CQA) •ISO 9001:2015, ISO 14001, ISO 45001, ISO 13485 Lead Auditor •ISO 22301 Internal Auditor •Exemplar Global Quality Management System Auditor •Professional Coach certification (IESEC Human) •Facilitator for Professional Formation (INFOTEP) •Business Continuity Certification (AMBCI) •Judge for the ASQ International Team Excellence Award (ITEA) Key achievements: •Reduced personnel turnover by 50% within one year. •Decreased rework costs by 39% and improved in-process non-conformities by 36% within one year. •Cut non-conformities by 70% and reduced raw material and product release times by 57% and 47%, respectively, within two years. •Participated in 100+ quality and regulatory audits, achieving zero major non-conformities in FDA, Korean FDA inspections, ISO 13485, and second-party audits. If you are seeking a leader to optimize your operations, drive quality excellence, and elevate organizational performance, feel free to reach out at moronta.alejandro@gmail.com.