HECTOR GUESTRIN

An experienced professional with solid education and demonstrated success in process management. Expertise in Medical Devices; Quality Management Systems for compliance with FDA, Health Canada and EU regulations and standards; Requirements Management; Risk Analysis; Quality Assurance; SW Verification & Validation; SW Configuration Management and SW development management. Highly analytic and problem solver. Good communication and presentation skills. Reputation for fine interpersonal and coaching skills. Effective management of local and remote teams. Experience in Biomedical Engineering, particularly in biomedical instrumentation and optical-fibre sensors for chemical and biological measurements. Fluent in English, Spanish and Portuguese... Implemented the Quality Management System (QMS) for medical device development under FDA and ISO 13485:2003 compliance

Primary location: Ottawa Canada