Dorothy Henckel
Dorothy Henckel
Dorothy Henckel has 20 years of experience working in the life sciences industry. As a consultant, Dorothy’s clients have ranged from small start ups to companies topping the Fortune 500 list. Her focus includes: medical device regulatory compliance, such as Warning Letter and Form 483 resolution; root cause analysis; complaint handling and adverse event reporting; recalls; labeling; supplier controls; design change review; quality systems auditing; risk management; corrective and preventive action (CAPA); process and design validation; ESG and CSR benchmarking; and Clinical Laboratory Improvement Amendments (CLIA).
Previously, she worked in the R&D, operations, and quality departments at a leading multinational diagnostics company, where she collaborated with other experts on nearly every aspect of the Firm’s quality systems.
Dorothy earned a Bachelor of Science in Chemistry from Indiana University, Bloomington, and holds Lead Auditor certifications from the International Organization for Standardization and Europe’s Medical Device Regulation.