Credentials
- PhD in Engineering
- Masters Degree in Quality Engineering
- Six Sigma Academy/ASQ Certified Black Belt
- American Association of Tissue Banks Certified Tissue Banking Specialist
- RABQSA Certified Lead Auditor of Quality Management Systems
- ASQ Certified Quality Engineer and Certified Quality Auditor
- 17 years experience in Medical Device and Tissue Banking Quality
- Experienced in Operations Management
- Experienced in Operations Engineering
- Experienced in training in many Quality and Compliance subjects including Statistics and Complaints & Medical Device Reporting, both domestically and internationally
- Experienced in preparation and submission of Medical Device 510(k)s as well as technical files & design dossiers
- Experienced in management of medical device corrections and removals
- Experienced in QMS process mapping and procedure writing
Specialties
- Six Sigma Black Belt (SSBB)
- Certified Tissue Bank Specialist (CTBS)
- Certified Quality Engineer (CQE)
- Certified Quality Auditor (CQA)
- Quality, Compliance, Process Improvement
- Domestic and Foreign – 21CFR and MDD
- Quality Engineering and Quality Control
- Quality Management Systems (QMS)
- ISO 13485
- QMS Remediation
- Training
- Corrective and Preventive Action (CAPA)
- LeanSigma
- Medical Device and Tissue Banking
- Automotive
- Factory Automation Systems
- Medical Device and System Software Validation and FDA Part 11 Compliance