Samantha Menendez
Lead Auditor @Intertek
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WORK HISTORY
Lead Auditor @Intertek
Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia, and/or Brazil, and/or GMP regulatory requirements related to the medical device, pharmaceutical and/or cosmetic industry. Assist clients with questions relevant to the audit and/or certification process. Act as Lead Auditor or team member. Coordinate audit activity with team members. Liaison with client regarding audit activity. Review client\'s quality management system documentation and verify and document evidence of compliance and non-compliance. Prepare audit report and review audit results with coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required. Assist with corrective action requirements resulting from assessments and participate in audit meetings. Review audit reports and provide technical assistance to the medical team. Support management in areas of continuous improvement. Provide management with updates on status of work, initiatives, and projects, as required.
EDUCATION
FIU College of Arts, Sciences & Education
Master's degree, Statistics
Florida International University - College of Engineering & Computing
Bachelor's degree, Biomedical Engineering
Miami Dade College
Associate’s Degree, Accounting and Finance
SKILLS
ABOUT SAMANTHA MENENDEZ
Lead Medical Device Auditor | Master of Statistics (M. Stat.) | Biomedical Engineer
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