Kyle Nakashima
Sr. Quality Engineer - CAPA at Abbott | Pleasanton, California, United States
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Kyle Nakashima is a seasoned Senior Quality Engineer at Abbott, where he leverages over a decade of experience in FDA-regulated industries, particularly within the medical device and pharmaceutical sectors. His expertise in managing Corrective and Preventive Actions (CAPA) is pivotal to ensuring compliance with stringent regulatory standards such as ISO 13485 and 21 CFR 820. In his current role, Kyle has successfully overseen more than 70 CAPAs across Abbott's global HF MCS sites, demonstrating his ability to navigate complex quality challenges while fostering collaboration among cross-functional teams.
Kyle's analytical mindset and commitment to evidence-based problem-solving are at the core of his professional philosophy. He firmly believes that thorough documentation is essential for effective quality management, as it provides the foundation for informed decision-making and continuous improvement. His proficiency in quality system compliance, combined with his hands-on experience with SAP ERP and Oracle Agile PLM, enables him to streamline processes and enhance operational efficiency.
In addition to his CAPA management responsibilities, Kyle plays a crucial role in guiding team members through the CAPA process, ensuring that all stakeholders are aligned and informed. His dedication to cleanroom compliance and adherence to FDA Good Manufacturing Practices (GMP) further underscores his commitment to maintaining the highest quality standards in product development and manufacturing. As a Certified Quality Engineer (CQE), Kyle continues to contribute to Abbott’s mission of delivering safe and effective medical solutions, reinforcing his reputation as a trusted expert in quality engineering within the industry.
Sr. Quality Engineer - CAPA at Abbott in January 2022 to Present
Quality Engineer II at BD in April 2021 to October 2021
Quality Engineer at BD in December 2018 to April 2021
CAPA Engineer II at Masimo in June 2018 to November 2018
CAPA Engineer at Masimo in April 2016 to May 2018
Quality Engineer (Contractor) at Medtronic in May 2015 to April 2016
QC Environmental Monitoring Technician at PYRAMID Laboratories Inc. in June 2014 to May 2015
R&D Engineering Intern at Implant Sciences Corp. in July 2013 to October 2013
Lab Intern at Parenteral Drug Association (PDA) in July 2012 to September 2012
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UC San Diego, Bachelor of Science (B.S.)
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GMP
Validation
SOP
Engineering
Pharmaceutical Industry
ISO 13485
Microsoft Office
SAP ERP
FDA GMP
Aseptic Processing
Cleanroom compliance
Technical communication for Engineers
21 CFR 820
Oracle Agile PLM
Corrective and Preventive Action (CAPA)
Change Control
Certified Quality Engineer (CQE)
Quality System Compliance
NCMR
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Discover more about AbbottWhat is Kyle Nakashima email address?
Email Kyle Nakashima at [email protected] and [email protected]. This email is the most updated Kyle Nakashima's email found in 2026.
How to contact Kyle Nakashima?
To contact Kyle Nakashima send an email to [email protected] or [email protected]. (updated on September 04, 2024)
What company does Kyle Nakashima work for?
Kyle Nakashima works for Abbott
What is Kyle Nakashima's role at Abbott?
Kyle Nakashima is Sr. Quality Engineer - CAPA
What is Kyle Nakashima's Phone Number?
Kyle Nakashima's phone (213) ***-*319
What industry does Kyle Nakashima work in?
Kyle Nakashima works in the Medical Devices industry.
Kyle Nakashima Email Addresses
Kyle Nakashima Phone Numbers
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