CQE with twenty seven years of experience in the Medical Device and Biomedical industries.  In- depth knowledge of Regulations and Standards:  QSR, ISO 13485, Canadian Medial Devices Conformity Assessment System (CMDCAS), ISO 14971, 21 CFR 1270 & 1271 (Human Tissue).

Titles Held: Vice-President, Quality Assurance; Director of Quality Assurance; Divisional Quality Assurance Engineering Manager; Quality Assurance Supervisor; Production Supervisor

• Substantive experience in Design Controls, Product Development, developing Quality System documentation such as Quality Manuals, Policies, SOP’s, Risk Management, CAPA, Supplier Audits
• Exceptional understanding of failure investigations, gap analysis, auditing, FDA & ISO inspections, remediation, company acquisitions, and Due Diligence experience
• Experience in responding to the FDA on 483’s and Warning Letters
• Successfully developed several quality systems for QSR and ISO 13485 compliance
• Extensive International QA and auditing experience in Mexico, France, England, Sweden and Japan

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

Regulatory and quality systems specialist with twenty-three years of medical device experience.  Excellent understanding of FDA, European, and Canadian requirements, 510(K) pre-market notifications, supplier quality management, process and software validation, risk management, project management, and statistical process control.

Titles Held: Quality Assurance Manger; Senior Process Engineer; Manager of Control Laboratory; Process Engineer

• Experience Conducting mock FDA inspections and QSR training
• Worked for Start Up companies to large medical device firms
• Managed quality systems registrations for US and European clients ISO 19385/6, CMDCAS
• Management and coordination of recalls and corrections, FDA inspections and related events
• Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA)

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