Mercedes Massana

A results-oriented and customer-focused Technical Leader with more than 30 years of technology-driven progressive expertise in the medical device industry. Technical expertise in quality, risk management, systems engineering, software development, requirements management, verification/validation activities, process improvement, project management and test engineering.

Specialties: Risk Management, Requirements Management, Verification and Validation, FDA Regulations, ASQ Certified Quality Manager, ASQ Certified Software Quality Engineer, ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor

A results-oriented and customer-focused Technical Leader with more than 30 years of technology-driven progressive expertise in the medical device industry. Technical expertise in quality, risk management, systems engineering, software development, requirements management, verification/validation activities, process improvement, project management and test engineering.

Specialties: Risk Management, Requirements Management, Verification and Validation, FDA Regulations, ASQ Certified Quality Manager, ASQ Certified Software Quality Engineer, ASQ Certified Quality Auditor, ASQ Certified Biomedical Auditor

Discussion with the customer about the problem that needs to be solved. A plan with the recommended solution and detailed costs. Deliverables as per the plan.