A highly skilled, International Quality veteran and effective leader with twenty-eight years experience in the Global Quality Movement.  Ability to employ a variety of quality methodologies required to support international technical and regulatory requirements.

Titles Held: Senior Consultant; Director of Quality; Quality Manager; General Manager; Project Manager of Reliability; Quality Engineer.

• Extensive experience with implementation, auditing, certification, and maintenance of ISO 13485:2003, ISO 9001:2000, 21CFR820 cGMP, MDD 93/42/EEC, TL, QS, TS, and several other standards
• Expert in international medical device product registrations for global projects from around the world, including: EU CE notified body marking for class II and class III products, China SFDA, Australia TGA , Brazil, Mexico, Canada CMDR / CMDCAS / CAMCAS, Central and South America, Russia device registration and Japan MGLW
• Skilled at creating and updating FMEAs under ISO 14971 risk management, fault trees, Mil-STD-1629, AIAG FMEA, and other risk methods for Hazard Based Safety Engineering
• Experience in the submission of technical files and product dossiers, pre-market notification and device licensing submissions; Canadian Licenses, FDA 510(k) Approvals & PMA Submissions
• Current ASQ certificates, several considered equivalent to a PE license; fluent in Spanish

Twenty years of experience in the Medical Device and Biotechnology industries developing, implementing and maintaining global regulatory affairs, compliance and quality assurance strategies and systems.  Strong background with FDA Quality Systems regulations, including ISO 9000:2000, 13485:2003, CMDCAS, MDD, IVDD and HIPAA requirements.

Titles Held: Director of Regulatory Affairs/Compliance Assurance; Senior RA Specialist; Manager of Quality Assurance; Senior Quality Engineer

• ISO certification and surveillance
• State licensing and Facility registration
• QM & SOP writing; Failure investigations
• International experience: Pakistan, Costa Rica, Mexico, EU, Canada, Japan and Australia; CE Marking
• Certifications: CQA, RAC, Lead Auditor Certification

Nineteen years of experience providing advice, facilitation and training on the development, administration, and technical aspects of quality improvement efforts for the Medical Device industry. Assist clients with compliance needs including FDA/ISO audits, needs assessments, creating quality systems and auditing.

Titles Held: VP of Quality and Compliance; Quality Assurance Manager; Plant Manager

• Due diligence audits, product complaints, Validation/Design control, CAPA’s
• Microbiology/Environmental monitoring; Aseptic processing and calibration
• Facilitation and training on the development, administration and technical aspects of quality improvement efforts for all levels/areas of quality
• Internal and External Quality-system assessments for compliance to FDA regulatory requirements and ISO and EN standards
• Certified Quality Auditor

Seasoned professional with thirteen of years experience in both Domestic and International Regulatory Affairs and Quality Systems. Strong 510(K) submission work and extensive knowledge of implementation of total quality system certifications for the Medical Device industry.

Titles Held: Manager of Quality Assurance and Regulatory Affairs; Senior Quality Engineer; RA Specialist

• Expert in Process and Software Validation; Knowledgable QSR Trainer
• Extensive experience with FDA Inspections and Quality system Audits
• Experience with Class II Intravascular Devices; clinical trials
• Experience working RA and QA systems in the US, EU, Asia Pacific and Latin America; CE Marking experience
• Certifications: RAC, ASQ, CQA, RAB-Certified Lead Quality Auditor