Devleena Kole
Manager, Quality Engineering at Element Biosciences | San Diego, California, United States
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Devleena Kole is a highly skilled Staff Quality Engineer at Element Biosciences, a pioneering startup dedicated to advancing genetic analysis tools for both research and diagnostic applications. With nearly a decade of experience in fast-paced, regulated environments, Devleena has established herself as a technical leader, adept at driving critical operational initiatives to fruition while maintaining a strong focus on quality and manufacturability.
In her current role, she serves as the primary Quality Engineering (QE) representative for both on-market and New Product Introduction (NPI) products, ensuring compliance with ISO 13485:2016 standards. Devleena is instrumental in developing robust frameworks that support quality deliverables, which are essential for the successful launch and sustainability of innovative genetic analysis solutions. Her leadership extends to managing a team of three inspectors in Incoming Quality Control (IQC), where she oversees resource allocation, priority management, and strategic growth initiatives, including the expansion of receiving inspection processes and the development of key performance indicators (KPIs).
Devleena's expertise encompasses a wide array of skills, including data analysis, risk analysis, and technical writing, all of which are critical in her role. Her proficiency in project management and documentation ensures that all processes are meticulously documented and aligned with regulatory requirements. Furthermore, her experience in research and development (R&D) and protocol design enables her to contribute significantly to the innovation pipeline at Element Biosciences. Devleena's commitment to quality and her ability to communicate effectively across multidisciplinary teams make her an invaluable asset in the quest to revolutionize genetic analysis technologies.
Manager, Quality Engineering at Element Biosciences in February 2025 to Present
Staff Quality Engineer at Element Biosciences in November 2023 to February 2025
Senior Quality Engineer II at Element Biosciences in July 2022 to November 2023
Senior Manufacturing Engineer II at Tandem Diabetes Care in February 2022 to June 2022
Senior Manufacturing Engineer I at Tandem Diabetes Care in August 2019 to February 2022
Process Engineer II at Illumina in October 2016 to August 2019
R&D Product Development Intern at Medtronic in June 2015 to September 2015
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UC San Diego, Master of Science (MS), August 2026
Clemson University, Bachelor of Science (B.S.), August 2026
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Biomedical Engineering
Medical Devices
Data Analysis
Process Improvement
Product Development
Project Management
Design of Experiments
Risk Analysis
Technical Writing
Science
Documentation
Manufacturing
Research and Development (R&D)
Engineering
Project Planning
Leadership
Team Building
Product Testing
Bioengineering
Experimentation
Protocol Design
Oral Communication
Clinical Engineering
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Discover more about Element BiosciencesWhat is Devleena Kole email address?
Email Devleena Kole at [email protected] and [email protected]. This email is the most updated Devleena Kole's email found in 2026.
How to contact Devleena Kole?
To contact Devleena Kole send an email to [email protected] or [email protected]. (updated on August 25, 2024)
What company does Devleena Kole work for?
Devleena Kole works for Element Biosciences
What is Devleena Kole's role at Element Biosciences?
Devleena Kole is Manager, Quality Engineering
What is Devleena Kole's Phone Number?
Devleena Kole's phone (213) ***-*298
What industry does Devleena Kole work in?
Devleena Kole works in the Medical Devices industry.
Devleena Kole Email Addresses
Devleena Kole Phone Numbers
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