Biomedical/Manufacturing Quality Engineer with nine years experience in Biomedical Research and Medical Devices. Primary focus is in the area of Quality Assurance, Process Improvement and Design Control.

Titles Held: Quality Engineer; Quality Control Scientist; Biological Chemist

• Skilled at performing Design Failure Modes & Effect Analysis (FMEAs), Process Control, Internal
• Corporate Audits and Risk Assessments
• Test Method Validation, Equipment Validation, DQ, IQ, OQ for New Product Development
• Exposure in launching products in Europe, Japan, Germany, Mexico and Puerto Rico
• Experience with Class III Implant Devices; Class I and II stints, surgical instruments, ENT and Cardio devices
• Working knowledge of governed audits within the FDA, CDC and EPA; strong Biochemist skill set

ASQ professional with twenty-two years of experience in regulatory compliance, project management and business process improvement. Industry experience in drugs, biologics, medical devices, IVDs, and tissue banking.

Titles Held: Director of QA/RA; Principal; Corporate Director of Quality /Regulatory; QA/RA Specialist; Project Coordinator, Manager of Clinical Services

• Proven capability to accomplish results in different countries and varied business functions
• Strong FDA applications for Biologics IND Phase O to III; FDA applications for medical devices and IVDs, IDE’s through PMA’s
• Experience with Quality programs, Design Control, SOPs, Assessments, Validation and CAPA’s
• US, EU, and CE Marking medical devices and diagnostics; EU and ISO quality management audits
• Experienced Auditor with QSR, EU, GC; prepared and received accreditation in EU GMP, QSR, ISO 13485, ISO 9001