Julie Byars
Principal, Co-Founder at Ontogen Medtech | Lisle, Illinois, United States
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Julie Byars is a seasoned leader in the medical device industry, currently serving as Principal and Co-Founder at Ontogen Medtech. With a robust background in quality management systems, Julie specializes in ensuring compliance with ISO 13485 and FDA Quality System Regulations (QSR), which are critical for the successful development and commercialization of medical technologies. Her expertise as a certified auditor and quality engineer allows her to effectively implement continuous quality improvement initiatives, tailoring quality systems to align with both organizational needs and regulatory objectives.
At Ontogen Medtech, Julie plays a pivotal role as the quality lead in the development of innovative medical device technologies. She collaborates closely with startups, entrepreneurs, and established companies across a diverse range of sectors, including active implantables, interventional cardiology, neurosurgery, and women's health. Her leadership in these key projects not only drives the advancement of cutting-edge medical solutions but also ensures that they meet stringent quality and safety standards.
Julie's skill set encompasses a wide array of quality assurance methodologies, including Corrective and Preventive Actions (CAPA), validation processes, and supplier quality engineering. Her problem-solving acumen and commitment to continuous improvement empower her teams to overcome challenges and enhance product reliability. As a quality auditing expert, she meticulously evaluates processes to identify areas for enhancement, ensuring that all projects adhere to the highest quality control standards. Through her dedication and expertise, Julie Byars is not only shaping the future of medical technology but also fostering a culture of excellence and compliance within the industry.
Quality Lead at Hubly Surgical in February 2021 to Present
Principal, Co-Founder at Ontogen Medtech in February 2021 to Present
Sr. Director, Product Quality at Endotronix, Inc. in April 2018 to February 2021
Quality & Regulatory Manager at Dabir Surfaces, Inc in October 2013 to April 2018
Engineering Supervisor at Medtronic Spine & Biologics in April 2012 to October 2013
Sr. Quality Engineer at Medtronic Spine & Biologics in January 2008 to April 2012
Technical Services Engineer at St. Jude Medical in June 2004 to January 2008
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Medical Devices
ISO 13485
Biomedical Engineering
CAPA
Quality System
GD&T
Validation
Minitab
Root Cause Analysis
Supplier Quality Engineering
Quality Management
Quality Assurance
Problem Solving
FDA
Manufacturing Engineering
Continuous Improvement
Quality Auditing
Quality Control
Geometric Dimensioning & Tolerancing
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
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Discover more about Ontogen MedtechWhat is Julie Byars email address?
Email Julie Byars at [email protected] and [email protected]. This email is the most updated Julie Byars email found in 2026.
What is Julie Byars phone number?
Julie Byars phone number is +19018484010.
How to contact Julie Byars?
To contact Julie Byars send an email to [email protected] or [email protected]. If you want to call Julie Byars try calling on +19018484010. (updated on November 04, 2024)
What company does Julie Byars work for?
Julie Byars works for Ontogen Medtech
What is Julie Byars's role at Ontogen Medtech?
Julie Byars is Principal, Co-Founder
What industry does Julie Byars work in?
Julie Byars works in the It Services And It Consulting industry.
Julie Byars Email Addresses
Julie Byars Phone Numbers
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