M
Martha Kadas
About
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Vice President Quality Systems
Lake Villa, Illinois, United States
Résumé
Jobs
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Vice President Quality SystemsJuul LabsJan 2018 - Dec 2021 (4 years)JUUL’s mission is to drive innovation to eliminate cigarettes. We are dedicated to improving the lives of the world’s 1.3 billion adult smokers by offering a true alternative to cigarettes utilizing state of the art engineering and pharmacodynamic solutions. Our team of scientists and engineers are focused on ongoing research and innovation to empower adult smokers to make the switch away from cigarettes.
Responsible for strategic leadership of the global corporate Quality System.- VP, Quality & RegulatoryAmeda IncJan 2015 - Jan 2018 (3 years 1 month)Ameda, Inc. is a leading provider of electromechanical medical devices and sterile accessories to the hospital, consumer and retail breastfeeding markets.
Led the QA/RA and Clinical Care / Customer Service operations including global Regulatory strategy and compliance, Quality Engineering, Supplier QA in US and Asia, Document Control, Training, Laboratory, Post-Market QA Technical Support and Complaint Handling (B2C) and Customer Service (B2B), as well as oversight of the sterilization program. Initiatives included Quality Management System remediation, gap analysis and transition to revised standards such as ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP), QA/RA strategy for manufacturing site transfers, NPD - Sr. VP Global QualitySterigenics International LLCFeb 2012 - Dec 2014 (2 years 11 months)Leading provider of contract sterilization services that delivers solutions to the medical device and pharmaceutical industries, using Ethylene Oxide (EO), Gamma and Electron Beam (E-Beam) irradiation. Sterigenics also provides process capabilities for Food Safety and High Performance Specialty Materials using Gamma and Electron Beam radiation technologies, and generates $350 million in annual sales.
Responsible for the global corporate Quality System across 40 locations in 12 countries in the Americas, Europe and Asia to meet FDA, ISO, MDD, JPAL, CMDR and other worldwide compliance requirements. - Director, Quality Assurance & Regulatory AffairsNatus Medical IncorporatedJan 2009 - Jan 2012 (3 years 1 month)Leading provider of medical devices, software and services for the Newborn Care, Neurology, Sleep, Hearing and Balance markets used in hospitals, clinics and laboratories worldwide generating over $250 million in revenue.
Directed teams responsible for the development and deployment of Quality Systems / Regulatory processes to meet FDA, ISO, MDD, JPAL, CMDR and other worldwide compliance requirements. Management Representative responsible for all Quality-related activities and results. - Director, Product Quality AssuranceFenwal Blood TechnologiesJan 2007 - Jan 2009 (2 years 1 month)Divested Transfusion Therapies division of Baxter International specializing in manual and automated collection of whole blood and blood components. Fenwal, Inc., operated as an independent entity employing 3700 with annual sales exceeding $600 million until purchase by Fresenius Kabi.
Directed corporate Product Quality Assurance operations including Quality Engineering, Post-Market Quality Assurance, and Sterility Assurance. Develop, design and implement global PQA strategy, systems, processes and continuous improvement plans. - Senior Quality ManagerBaxter healthcareJan 2005 - Jan 2007 (2 years 1 month)Multi-faceted medical products and pharmaceuticals company assisting the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma.
Managed Quality Engineering team responsible for the design, development, and on-market management of Disposable Kit and Hardware and Software Quality Engineering for manual and automated blood collection and separation instrumentation as well as distributed OEM equipment. - Quality Assurance ManagerAbbott DiagnosticsJan 1995 - Jan 2005 (10 years 1 month)Diagnostics Division is a leading provider of diagnostic test systems to hospitals and national laboratories.
Managed team of quality professionals responsible for product quality of medical devices including: final product release and monitoring of field performance, new product development, specification setting, design control verification / validation, risk management, and complaint investigation. Internal and external audit management. Failure investigation and product improvement using Six Sigma problem solving tools. - DAccount ExecutiveDaigger ScientificJan 1989 - Jan 1995 (6 years 1 month)Leading distributor of laboratory equipment, supplies and instruments.
Responsible for inside/outside sales of laboratory supplies and equipment to National Accounts. Served as technical liaison between manufacturers and laboratory personnel. - Sales RepresentativeSargentWelch Scientific CompanyJan 1988 - Jan 1989 (1 year 1 month)Leading supplier of laboratory equipment and science education materials, a Division of VWR Scientific.
Exceeded territory quota in inside sales of laboratory supplies and equipment.
Education
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- B.S, Biology, PsychologyUniversity of Illinois UrbanaChampaignJan 1983 - Jan 1988 (5 years 1 month)