H.E.W.

PECULIAR — Thu, 30 Oct 2008 16:51:55 +0000

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

D.J.C.

PECULIAR — Thu, 30 Oct 2008 14:43:41 +0000

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

Medpoint » Business Process Improvement

H.E.W.

D.J.C.