Mercedes Massana
Principal Consultant at MDM Engineering Consultants
- Role
- President at Mdm Engineering Consultants
- Location
- Hollywood, FL, US
- LinkedIn followers
- 500 followers
About 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
Experience
President
Aug 2009 — Present · Pembroke Pines, FL, US
Provide consulting services to pharmaceutical and medical device companies in the areas of Quality Assurance, Risk Management, Product Development, Process Improvement, Design Verification & Validation, Software Quality Assurance, Systems Engineering, Requirements Management, Process Validation and Project Management. Rework and re-structure of Quality Management Systems to ensure compliance with regulatory requirements and improve effectiveness of product development process. Design History File and Risk Management File remediation. Provide training in the areas of Verification & Validation, Requirements Development, Requirements Management, Risk Management and Design Controls.
Education
University of Miami
BSEE, Electrical Engineering
1980 — 1984
Skills
- Risk Management
- Design Control
- Continuous Improvement
- Assurance Cases
- 21 Cfr Part 11
- Design of Experiments
- Manufacturing
- Computer System Validation
- Process Improvement
- Validation
- Software Validation
- R&D
- Quality Engineering
- Iso
- Sop
- Fda
- Quality Control
- Gmp
- Lean Manufacturing
- Process Validation
- Testing
- Process Engineering
- Biomedical Engineering
- Iso 14971
- Quality Assurance
- Fmea
- Qsr
- Quality System
- Quality Systems
- Product Lifecycle Management
- V&V
- Product Life Cycle Management
- Systems Engineering
- Software Documentation
- Sdlc
- Root Cause Analysis
- Requirements Management
- Change Control
- Medical Devices
- Capa
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