Kristina Spadafora
Quality Assurance Manager; ELITechGroup Molecular Diagnostics at ELITechGroup Molecular | Seattle, Washington, United States
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Kristina Spadafora serves as the Quality Assurance Manager at ELITechGroup Molecular Diagnostics, where she leverages her extensive expertise in quality management systems to ensure compliance with industry standards and regulatory requirements. With a robust background as a Quality Medical Device Management Systems Lead Auditor, Kristina is well-versed in ISO 13485:2016 and FDA 21 CFR 820, making her an invaluable asset to the organization. Her role involves managing quality records and overseeing the customer complaint system, ensuring that all feedback is meticulously documented and addressed.
In her capacity, Kristina coordinates Corrective and Preventive Actions (CAPAs) and non-conformities, guiding her team through comprehensive root cause analyses to foster continuous improvement. She is adept at collecting and organizing data that measures the effectiveness of the Quality Management System (QMS), which is crucial for maintaining high standards in product quality and safety. Her leadership extends to coordinating and hosting Management Reviews and Global Standardized Management Reviews, where she presents key findings and strategic recommendations to enhance operational efficiency.
Kristina's experience spans various regulatory frameworks, including ISO 17025, ISO 9001, and NNHPD, which equips her with a well-rounded perspective on quality assurance in the medical device and dietary supplement industries. Her commitment to cross-functional team leadership and business process improvement drives a culture of quality within ELITechGroup, ensuring that the organization not only meets but exceeds industry standards. With her strong focus on training and team building, Kristina is dedicated to fostering a collaborative environment that empowers her colleagues to uphold the highest quality standards in molecular diagnostics.
Quality Assurance Manager; ELITechGroup Molecular Diagnostics at ELITechGroup Molecular in April 2019 to Present
Director of Operations at ELITechGroup Molecular in April 2022 to Present
Senior Director: QA/QC, Scientific & Regulatory Affairs (SRA) & Product Commercialization at Univera, Inc. in December 2012 to April 2019
Senior Director: Product Commercialization, Scientific and Regulatory Affairs (SRA) & QA/QC at Univera, Inc. in October 2012 to April 2019
Quality Assurance Officer at Eurofins Frontier Global Sciences in December 2007 to October 2012
Project Manager at Eurofins Frontier Global Sciences in April 2005 to December 2007
Inorganic Chemist at Water Management Laboratories in February 2003 to April 2005
Quality Assurance Engineer/Chemical Engineer at Nippon Chemi-Con Corporation in November 2000 to January 2003
Special Chemist at Pacific Northwest Sugar Company in August 1998 to October 2000
First Research Assistant at MSU College of Veterinary Medicine, Analytical Support and Food Safety Laboratory in March 1997 to April 1998
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Discover more about ELITechGroup MolecularWhat is Kristina Spadafora email address?
Email Kristina Spadafora at [email protected]. This email is the most updated Kristina Spadafora email found in 2026.
What is Kristina Spadafora phone number?
Kristina Spadafora phone number is +12066501583 and +14257454373.
How to contact Kristina Spadafora?
To contact Kristina Spadafora send an email to [email protected]. If you want to call Kristina Spadafora try calling on +12066501583 and +14257454373. (updated on September 13, 2024)
What company does Kristina Spadafora work for?
Kristina Spadafora works for ELITechGroup Molecular
What is Kristina Spadafora's role at ELITechGroup Molecular?
Kristina Spadafora is Quality Assurance Manager; ELITechGroup Molecular Diagnostics
What industry does Kristina Spadafora work in?
Kristina Spadafora works in the Software Development industry.
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