Valarie Chavez
Quality Assurance Manager at Sterigenics
Based in Orange, United States
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Seniority
Manager
Department
Other
Location
Orange
Industry
Medical Equipment Manufacturing
Company size
1.1K
Contact information
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v•••••••@sterigenics.com
Phone
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Background
About Valarie Chavez
Expertise and proven track record in Quality Assurance and FDA Regulation across multiple industries- Medical devices, Cosmetics, Tobacco Products, OTC Drugs, and Food Safety. QMS/Regulatory compliance for ISO 9001 Manufacturing, ISO 17025 testing labs, and International markets. Technical Background-Microbiological research & Analytical Chemistry -R&D, Testing methodology development, continuous monitoring -QMS Optimization, SOP development, company training -QMS Compliance for FDA, ISO, & Global markets -FDA market submission & Product launch (510k, PMTA, OTC drug)-Auditing, Risk/Gap Assessments, and Remediation -Quality Engineering, Process Design and Qualification -Business Improvement (Six Sigma & Lean)
Decision-makers
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