Vice President of Quality & Regulatory at LightForce Orthodontics in Onsite in Wilmington, MA

Job description

About LightForce LightForce is leading the digital transformation of orthodontics and redefining the standard of care for patients. Our fully digital, 3D-printed orthodontic platform increases practice efficiency, improves clinical consistency, and enables more predictable treatment outcomes. Unlike traditional stock brackets, LightForce delivers fully customized, patient-specific brackets paired with AI-driven treatment planning—optimizing outcomes at scale. With recent advancements unlocking the next phase of digital orthodontics, LightForce continues to push the boundaries of what’s possible in personalized care. Learn more at www.lf.co The Opportunity LightForce is looking for a VP of Quality & Regulatory to build the organization, systems, and culture that will carry us through our next stage of commercial scale. You'll inherit a Quality function that has successfully supported product development and early commercialization — and you'll be the one who takes it to the next level. This isn't a gatekeeper role. You'll build rigorous, scalable systems that let LightForce move fast precisely because quality and regulatory thinking are built in from the start, not bolted on at the end. You will participate on the Executive Leadership Team as the company's senior voice on product quality, patient safety, and regulatory strategy — with real influence over how we build, not just whether we ship. What You'll Do Own the Quality Management System Strengthen and scale the LightForce QMS in line with FDA requirements, ISO 13485, and other applicable global standards — practical and rigorous, not bureaucratic. Establish sustained audit and inspection readiness and management reviews that actually drive decisions. Lead Process Quality Build a strong process quality capability with Operations — process control, SPC, validation (IQ/OQ/PQ), and quality-at-the-source practices. Use data and trend analysis to catch emerging issues before they become systemic, driving the shift from inspection toward prevention. Drive Root-Cause Discipline Own the effectiveness of the nonconformance and CAPA systems, with rigorous root-cause investigation and closed-loop learning back into design, process, and training. Champion Design & Software Quality Partner with Product, Hardware, Software, and Clinical throughout development — not just at release — on design controls, DHFs, verification/validation, and risk management. Own Regulatory Strategy & Execution Set LightForce's global regulatory strategy, lead submissions and filings, and serve as senior company representative with FDA, Notified Bodies, and other authorities. Build the Organization Recruit and develop leaders and specialists across Quality Engineering, Regulatory, Supplier Quality, and Complaints/CAPA, with real succession depth. Build an executive quality dashboard, and report performance and risk to the ELT and Board. What You Bring Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical field. 12+ years of progressive quality leadership in regulated medical devices, including significant commercial-manufacturing quality responsibility, with at least 5 years leading a substantial Quality organization or major function. Deep knowledge of FDA medical-device requirements, ISO 13485, design controls, risk management, CAPA, process validation, and supplier quality. A track record leading FDA, Notified Body, and other regulatory interactions and audits, and developing regulatory strategies and submissions for commercial devices. Demonstrated use of quality engineering and statistical methods to prevent problems, not just catch them. Who Thrives Here We're looking for someone who has seen this scaling journey before — who knows how a Quality and Regulatory organization needs to evolve as a medtech company moves from early commercialization into real scale. You hold an independent quality voice with the confidence to challenge senior leaders when it matters, but you're pr