• Quality Systems Professional with 20+ years of experience in Medical Device & Pharmaceutical Industries.
• Seasoned Project Manager & Consultant with proven ability to achieve / maintain compliance with domestic / international regulations.
• In depth knowledge of Audits, Supplier Quality Management, New Product Development, Validations, Corrective Action Preventive Action (CAPA), Quality Systems Remediation & FDA 483 Resolution.
• Extensive front room experience with FDA. 510K Submissions, EU-MDR Transition
• Managed 3 plants in different locations. Designed and built a plant from the ground up in Tulsa Oklahoma
• Over 20 years of experience-ISO13485, AS 9100
• Certifications: Six Sigma Master Black Belt, Lean Master, BSI certified MDSAP and ISO13485 Auditor, ASQ CQE, SCRUM Master
• Trained in the TPS , at a Toyota plant and in Japan. Set up true one-piece flow systems in numerous locations and have led over 150 kaizen events
• Worked with cross-functional teams for over 20 years and believe in fostering a team environment in which all stakeholders play a part in the process

SKILLS

• Six Sigma Master Black Belt - 10+ years ASQ Certified Quality Engineer - 10+ years
• Lean Manufacturing Master - 10+ years
• 510K Submissions- 10+ Years
• PMP – Certified Project Management Professional – 7 yrs.
• ISO 13485:2016, EU MDR 2017/745 - 10+ years
• ISO 14971-Risk Management - 10+ years
• FDA Inspections- Front & Back-room experience - 10+ years Design History File Remediation - 10+ years
• Agile Product Quality Management - 3 years FMEA\PPAP\AQPQ\3P\A3\8D\ CAPA - 10+ years
• BSU / ISO 13485:2016 Certified Lead Auditor (BSI) - 5 years
• Process Validation/ extensive experience in IQ/OQ/PQ- 10+ years
• Corrective Action Preventative Action (CAPA) - 10+years
• EU MDR Transition – 6 years
• Spanish - Fluent (Read, Write, Speak) - 10+ years
• Serbo-Croat - Intermediate (Read, Write, Speak)- 10+ years