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