Sergio Gazel

Background

About Sergio Gazel

Professional with 16 years of Managerial experience. 23 years’ experience in Medical Device or Pharmaceutical multinational companies. Area of expertise include: Quality Systems, ISO 13485 and ISO 9001 certification processes, FDA (QSR Regulations, 510K, PMA), Process and Software Validation, Risk Management, Complaint Management, CAPA, Management Review, Quality Engineering, Quality Operations, Supplier Quality, Six Sigma, Lean Manufacturing, Operational Excellence, Project Management, Supply Chain Management, Strategic Management, Leadership, Change Management, Cultural Organization Management and People Development. With relevant achievements in quality system improvements, defect reduction, CAPA Investigations, cost reductions, inventory reduction, business process optimization, and waste elimination. Successful Implementation of: product transfers, new product introductions, plant startups, and leaded successfully ISO 13485 Certification process, supported FDA inspections for startups and normal operation. Industrial Engineer with MBA. Holds the following certifications: ISO 13485 Lead Auditor (RABQSA), CPIM (APICS), Baxter Six Sigma Engineer, and Six Sigma Black Belt (ASQ). University Professor of Industrial Engineer courses (Quality Engineering and IE Advance Topics). A practical person, with proven results in developing people, effective leadership; oriented to: achieving results, continuous improvement, and teamwork.