ABOUT ME
Here to Serve You
Leader of quality system implementation, integration & remediation. I turn around, strengthen & improve multinational quality systems in order to meet complex stakeholder & regulatory requirements, while optimizing business value & profitability. I am recognized for my natural ability to mobilize multidisciplinary teams & my decisive, solution-oriented approach to address highly dynamic & challenging business needs. An empirical thinker with advanced skills in conducting research, executing process improvements & communicating results.
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Education:
• Doctor of Business (DBA), Student
• Masters of Business Administration (MBA)
• Bachelors of Science in Business, Business Management (BSB-BM)
• ASQ CQM/OE - Manager of Quality & Organizational Excellence
• ASQ CQE - Quality Engineer
• ASQ CSSBB - Six Sigma Black Belt
• ASQ CQA - Quality Auditor
• Certified Lead Auditor: ISO 13485 (MDSAP), ISO 9001, ISO 14001 & ISO 18001
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Career:
• led over 80 cGMP audits in the medical device industry; qualified lead auditors
• International business experience in Asia, Australia, Europe and the Americas
• Implemented ISO certified systems & proficient w/ISO 13485, 14971, FDA 21 CFR 820 & MDSAP
• Facilitated strategic assessment & on-boarding of suppliers over several corporate acquisitions
• Managed direct and indirect groups of large (25+) and small (5-) sizes
• Created Medical Device Quality Auditor course (CEMD 0960), used at 10+ colleges across the U.S.
Specialties:
• Quality System Implementation, Integration & Remediation
• FDA Readiness & Response
• Supplier Selection, Qualification & Management
• Quality Engineering & Project Management
• Auditing Compliance & Effectiveness
• Corrective & Preventative Action (CAPA)
• Advanced Root Cause Analysis
• Manufacturing Transfer
• Risk Management / APQP, FMEA, Control Plans, MSA & SPC
• Process Validation, Sampling Plans & Change Management