Julie Wilhelmson
Julie Wilhelmson is a seasoned Quality and Regulatory professional with over eighteen years of experience in the medical device industry, including more than a decade dedicated to quality assurance. Throughout her career, she has held progressive leadership roles focused on Design Quality Assurance, Verification/Validation, Risk Management, Supplier Quality, and Regulatory Compliance for Class II, IIa, and III medical devices. Julie’s expertise spans quality systems, audits, CAPAs, NCMRs, and regulatory standards such as ISO 9001, ISO 13485, and ISO 14971. Known for her pragmatic and fiscally responsible approach, she is committed to building high-performing teams through coaching, mentoring, and employee engagement.
Currently serving as Sr. Supplier Quality Engineer and R&I Supervisor at Bracco Medical Technologies, Julie leads quality initiatives that enhance compliance, efficiency, and product excellence. Her professional journey also includes leadership roles at Baxter International, Surmodics, Onto Innovation, and Summit Medical, where she consistently drove operational improvements, team development, and cross-functional collaboration. Julie combines technical expertise with strong interpersonal skills, leveraging her StrengthsFinder themes—Input, Responsibility, Deliberative, Intellection, and Empathy—to guide decision-making, anticipate risks, and cultivate trust within her teams.
Julie’s dedication extends beyond her professional achievements. She has contributed as a volunteer with AmeriCorps and managed accounts for youth sports programs, demonstrating a commitment to community service and leadership. Holding a Bachelor’s degree in Chemical Engineering from the University of Wisconsin-Madison and certifications including ISO 13485:2016 Lead Auditor and Design Failure Mode and Effects Analysis, Julie blends technical rigor with a people-centered approach, ensuring quality, compliance, and continuous improvement in the medical device industry.
• ISO 13485:2016 Lead Auditor Certification
• Design Failure Mode and Effects Analysis Certification
• Influential Communication
• Mini MBA Program
• University of Wisconsin-Madison- Bachelor's
• AMS
• Americorps - MathCorps
What do you attribute your success to?
I attribute my success to being open to learning new things, pursuing continuing education, staying determined, and leading my team effectively. I also have a passion for reading fiction and psychology journals, as well as gardening and cooking.
What’s the best career advice you’ve ever received?
The best career advice I’ve ever received is to believe in yourself, never give up, and strive to make a difference every day.
What advice would you give to young women entering your industry?
My advice to young women entering my industry is to go for it—the sky is the limit—be confident, take action, and always keep learning.
What are the biggest challenges or opportunities in your field right now?
The biggest challenges in my field right now are keeping up with rapid IT changes and meeting growing demand.
What values are most important to you in your work and personal life?
The values most important to me in my work and personal life are resilience, determination, and always striving to be my best.