Experience

StimLabs

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Director Quality

  • Mar 2020 - Present

  Roswell, Georgia, United States Lead Quality evolution & initiatives for a regenerative medicine company specializing in the design, manufacture, and marketing of minimally manipulated amniotic tissues for homologous use. Responsible for Quality system and oversight for human tissue products as well as medical devices and more complex biologics.



SRH Consulting

• Principal Quality Systems Consultant

  • 2009 - 2020

  Worldwide Provide consulting worldwide quality systems compliance, and regulatory consulting services to the medical device and diagnostic industry for conformance with FDA regulations, EU requirements, Canadian requirements, Australia requirements, and ISO Standards. Specialties include: Quality System & Compliance Assessment Audits Customized Training Programs FDA & ISO 13485, 14971 Baseline Assessment Audits FDA Response Remediation Strategy & Execution Compliance Certification… Show more Provide consulting worldwide quality systems compliance, and regulatory consulting services to the medical device and diagnostic industry for conformance with FDA regulations, EU requirements, Canadian requirements, Australia requirements, and ISO Standards. Specialties include: Quality System & Compliance Assessment Audits Customized Training Programs FDA & ISO 13485, 14971 Baseline Assessment Audits FDA Response Remediation Strategy & Execution Compliance Certification Audits Field Correction Due Diligence Audits Complaint Management & Vigilance Reporting CAPA Programs & Management Change Control & Document Management Processes Computer System Validation Support Quality Plans Supplier Management Programs Internal Audit Programs Show less



Volcano Corporation

• United States
• Medical Equipment Manufacturing
• 200 - 300 Employee

• Manager, Complaint Handling and Medical Device Reporting (MDR)

  • 2008 - 2009

  Responsible for the restoration of worldwide compliance and efficiency of the complaint handling, medical device reporting and pharmaco-vigilance processes for the US and sister sites in Canada, Europe and Japan.



CIBA Vision

• Medical Equipment Manufacturing
• 700 & Above Employee

• Corporate Manager,Quality Systems Compliance

  • 1995 - 2008

  Responsible for the development and execution of a global quality systems utilized in North America, Asia Pacific, Europe, Australia, Japan; some implemented within 72 international company sites worldwide. With primary focus in Customer Complaint Handling, Medical Device Reporting, Pharmacovigilance, Corrective and Preventive Action, Field Action, Internal Audit and Supplier Managment programs, Document and Change Control.