ORLANDO, FL – For Christina Arnt, quality in the medical device industry isn’t a checklist – it’s a strategic differentiator with direct consequences for patient safety.
“Quality, if done right, isn’t just about compliance,” she said. “It can actually be a competitive advantage.”
Arnt would know. She’s spent her career putting that philosophy into practice, holding key leadership positions at Baxter Healthcare, St. Jude Medical, and most recently, as VP of Global Corporate Quality at Zimmer Biomet, where she built and led quality systems across a wide range of products from orthopedics to software-driven technologies.
And now Arnt is stepping into a new role as QualityHub’s VP of Medical Device Compliance with a clear goal of helping manufacturers not just identify problems, but resolve them for good.
The US Food and Drug Administration (FDA) is “very good at finding gaps,” Arnt said. “One of the strengths I bring to QualityHub is the perspective of how to actually solve those gaps inside a complex organization.”
That practical lens is what drew her to QualityHub as the next step in her professional journey. The consultancy has a stellar reputation for being stacked with former FDA officials, something Arnt says is exciting and different from her past roles.
“You can have the best processes in the world, but if people don’t understand how quality connects to their work, it won’t last.” – Christina Arnt
“You don’t always get the chance to learn from people at that FDA regulatory level once you’re deep into your career,” she said. But at QualityHub, “you’re surrounded by people who are really plugged into where the industry and the FDA are going.”
At the same time, Arnt sees her role as balancing QualityHub’s ex-FDA expertise with hands-on industry know-how. Having worked across multiple sectors – including cardiac, orthopedics, dialysis, and Software as a Medical Device, or SaMD – she understands the operational challenges companies face when regulators say, “fix it.”
“There’s often this perception that everything can be solved quickly,” Arnt said. “But when you’ve been inside these organizations, you know how many moving parts there are.”
Her experience leading large compliance remediation efforts and guiding quality systems integrations after merger and acquisition closures will be particularly valuable as QualityHub continues to support its valued clients through high-pressure situations. And just as important, Arnt said, is helping device companies build a Culture of Quality that actually sticks.
“A big part of my new role at QualityHub will be meeting teams where they are and helping drive real culture change,” Arnt said. “You can have the best processes in the world, but if people don’t understand how quality connects to their work, it won’t last.”
After years working on the inside at MedTech firms, Arnt said she was ready to make a different kind of impact. Instead of focusing on a single organization, she now has the opportunity to help multiple companies and, ultimately, more patients.
“I always thought I’d end up at a consultancy at some point. Now, I didn’t expect that to happen this soon into my career, but it feels like the right move at the right time,” she said. “I’m ready to roll up my sleeves and get to work helping MedTech companies make products of high quality that advance the public health.”
Founded in 2004 on the principles of quality and a commitment to continuous improvement, QualityHub provides support in an array of technical areas, including product and quality system development, auditing, complaint handling, supplier control, clinical compliance, training, and much more. Discover what QualityHub’s compliance consultants, project managers, and regulation experts can do for your company today.
