Nineteen years of experience providing advice, facilitation and training on the development, administration, and technical aspects of quality improvement efforts for the Medical Device industry. Assist clients with compliance needs including FDA/ISO audits, needs assessments, creating quality systems and auditing.

Titles Held: VP of Quality and Compliance; Quality Assurance Manager; Plant Manager

• Due diligence audits, product complaints, Validation/Design control, CAPA’s
• Microbiology/Environmental monitoring; Aseptic processing and calibration
• Facilitation and training on the development, administration and technical aspects of quality improvement efforts for all levels/areas of quality
• Internal and External Quality-system assessments for compliance to FDA regulatory requirements and ISO and EN standards
• Certified Quality Auditor