Influential Women Profiles Julie Wilhelmson: Leader in Quality and Regulatory Excellence in the Medical Device Industry
Eden Prairie, Minnesota – Julie Wilhelmson is a seasoned Quality and Regulatory professional with more than eighteen years of experience in the medical device industry, including over a decade dedicated to quality assurance. Throughout her distinguished career, she has held progressive leadership roles centered on Design Quality Assurance, Verification and 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 an in-depth command of regulatory standards such as ISO 9001, ISO 13485, and ISO 14971. Recognized for her pragmatic, balanced, and fiscally responsible approach, she is committed to building strong, high-performing teams through coaching, mentoring, and meaningful employee engagement.
Currently serving as Senior Supplier Quality Engineer and R&I Supervisor at Bracco Medical Technologies, Julie leads initiatives that elevate compliance, operational efficiency, and overall product excellence. Her career includes impactful leadership roles at Baxter International, Surmodics, Onto Innovation, and Summit Medical, where she consistently drove process improvements, strengthened quality systems, and fostered cross-functional collaboration. Julie brings a rare combination of technical rigor and interpersonal insight, leveraging her StrengthsFinder themes—Input, Responsibility, Deliberative, Intellection, and Empathy—to guide thoughtful decision-making, anticipate risk, and cultivate trust across organizations.
Julie holds a Bachelor’s Degree in Chemical Engineering from the University of Wisconsin–Madison and maintains advanced certifications, including ISO 13485:2016 Lead Auditor and Design Failure Mode and Effects Analysis. She attributes her success to her commitment to continuous learning, her determination to overcome challenges, and her dedication to leading teams with clarity and purpose. Julie also acknowledges the support of her family, whose encouragement has been foundational to her professional growth.
Her commitment to service extends beyond the workplace. Julie has volunteered with AmeriCorps and has managed accounts for youth sports programs, reflecting her dedication to strengthening both community and industry. She credits her career philosophy to a guiding piece of advice she received early on: believe in yourself, never give up, and strive to make a difference every day. It is a message she now shares with young women entering the medical device field, encouraging them to remain confident, take action, stay curious, and embrace opportunities—because the sky, she emphasizes, is truly the limit.
Julie sees immense challenge and opportunity in the rapid technological evolution shaping the medical device landscape. Increasing regulatory demands and innovation cycles push her to remain adaptable, forward-thinking, and committed to continuous improvement. Through every advancement and obstacle, she remains grounded by her core values—resilience, determination, and an unwavering commitment to being her best—while keeping her family at the heart of everything she does.
Outside of her professional work, Julie enjoys reading fiction and psychology journals, gardening, and cooking, finding balance and inspiration in the activities she loves.
Learn More about Julie Wilhelmson:
Through her Influential Women profile, https://influentialwomen.com/connect/julie-wilhelmson
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