Marcelo Trevino

Marcelo Trevino is a highly experienced professional with over 20 years of expertise in Quality and Regulatory Affairs, specializing in medical device quality management systems and global medical device regulations.

He holds a B.S. degree in Industrial and Systems Engineering, complemented by an MBA in Supply Chain Management from the prestigious W.P. Carey School of Business at Arizona State University.

Marcelo is a certified Quality Management Systems Lead Auditor by Exemplar Global and has actively consulted with corporate executives in the medical device industry to drive process and quality improvement initiatives.

His vast professional background includes working on Lean Six Sigma Projects, Quality/Regulatory Affairs initiatives worldwide, Third Party Auditing through Notified Bodies, Supplier Audits, and consistent publications aimed at enhancing organizational quality and regulatory compliance.

As an ASQ Certified Six Sigma Black Belt & Biomedical Auditor, Marcelo possesses a plethora of certifications including RABQSA-Exemplar Global Certified QMS Auditor, with deep knowledge in areas such as GMP, Lean Manufacturing Operations, Design Controls, Verification/Validation Activities, and an array of Management Systems standards.

His technical expertise spans across a wide range of domains including Medical Devices, Biologics, Drug/Combination Products, Pharmaceuticals, and Management Systems such as ISO 9001, ISO 14001, ISO 27001, among others.

Marcelo Trevino's educational journey includes studies at renowned institutions like Arizona State University, UC Irvine, and Tecnológico de Monterrey.

He has held key leadership positions including President at Tregmedical, Global Vice President at Agendia, Inc., Senior Vice President at Applied Medical, Senior Director at Nihon Kohden America, among other prominent roles in organizations like Medtronic, Towerjazz, Coca-Cola Enterprises, and BSI.

Marcelo's technical competencies extend to FDA regulations such as 21 CFR 801, 803, 806, 807, 820, 821, 822, 830, and compliance with EU MDR regulations.

His professional goals include promoting environmental sustainability, as showcased by his certifications in Environmental & Sustainability Management.

In summary, Marcelo Trevino is a distinguished professional with a robust background in Quality and Regulatory Affairs, offering profound expertise in medical devices, quality management systems, regulatory compliance, and a proven track record of leadership in various renowned organizations.