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

Certified Quality Auditor with twenty-five years of experience.  Extensive broad-based knowledge in Quality Assurance with a successful record of introducing and implementing quality systems across multiple locations.

Titles Held: Director of Quality Assurance; Manager of Design Assurance; Manager of Quality Assurance; Senior Project Engineer; Quality Control Engineer

• Vast exposure to Medical Device Regulations including cGMPs and ISO 13485:2003
• Experienced engineer with a passion for new product development; well-versed in submission work as well
• Strong in Design Controls, CAPA’s and Quality Systems implementation
• In-depth knowledge of Class II, disposables, surgical instruments and catheters
• Quality Assurance experience in Europe, Asia, Ireland, China and Germany

Senior Manager with thirty-two years of extensive experience in the Medical Device field.  Strong skill set in Quality Assurance and Regulatory Affairs with ASQ and CQM certifications.

Titles Held: Director of QA/RA; Quality & Regulatory Manager; Quality Services Manager; Quality Assurance Manager; Clinical Laboratory Supervisor

• Qualified in Regulatory activities including 510(k) submissions, foreign country product registrations, product device master records, and EU MDD technical file maintenance
• Extensive experience with implementing Quality Systems compliant with FDA (QSR) and applicable regulatory standards such as MDD 93/42/EEC, ISO 13485, FCC, RTTE, and EMC requirements
• Experience in process and equipment validation including processes in EtO and Gamma Sterilization
• Effectively implemented a plant-wide ISO-9000 certification which resulted in certification by BSI to EN 29001 and EN 46001
• Strong experience with Electromechanical, Mechanical, Electronics, and Capital Equipment

Thirty-five years of experience in Regulatory (FDA) Submissions, FDA and ISO Quality Systems for the Medical Device and IVD industry.  Additional experience with Quality Assurance, Manufacturing, Clinical Affairs, Medical Services, Customer Services and Instrument Repair Services.

Titles Held: Vice President of Quality Assurance/Regulatory Affairs; Vice President of Clinical, Quality and Regulatory Affairs; Director of QC/QA

• Clearance and Approval of over thirty-five 510(k)’s, PMAs and BLAs
• Managed three IVD corporations to ISO 9001 and 13485 Certifications
• Developed and Commercialized 8 lVD’s (R&D)
• CE Marking, Canadian Product Registrations, experience working in Germany and Japan
• Extensive knowledge of In-Vitro Diagnostics, all classes including Biologics

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

Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas.  Specialty is working on the pre-meetings and briefings with the FDA.

Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist

• Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
• Strong international experience including international product registrations, CE mark approvals and import/export activities
• Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
• Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
• RAC certified with extensive knowledge with combination drugs devices

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