VP of Quality and Regulatory

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 is possible in personalized care. Learn more at The Opportunity LightForce is scaling fast, and we need an operations leader who can turn that growth into a world-class manufacturing organization. This is a builder's role: you'll take a fully digital, 3D-printed medtech manufacturing operation from early-scale to a disciplined production system capable of supporting a business well beyond $250M in revenue. You'll have real ownership - of strategy, of the P&L levers that matter (throughput, yield, capacity, cost), and of a growing team. You'll report directly to the President and work shoulder-to-shoulder with the executive team and board on some of the most consequential decisions in the company's next chapter. What You'll Do Set the Manufacturing Strategy Build the multi-year manufacturing roadmap that turns commercial demand into capacity, technology, and capital plans - staying ahead of growth without overbuilding. Partner with Engineering, Supply Chain, Quality, Finance, and Commercial on long-range plans, and give the executive team and board a clear, honest read on performance and risk. Own Production Performance You will bring a Quality First mindset to production, and understand that Quality is the underpinning of success, gross margin, productivity, yield, on-time delivery, and cost across a multi-shift production environment. Take day-to-day accountability for throughput, cycle time, yield, on-time delivery, and cost across a multi-shift production environment. Build a frontline leadership structure that stays close to the work and solves problems at the root cause - fast. Build Technical Operations & Drive Automation Stand up a strong Manufacturing Engineering/Technical Operations function covering process development, equipment engineering, validation, and continuous improvement. Lead a practical automation strategy - knowing where technology creates real value and where it doesn't, and building the internal capability and partnerships to execute. Lead NPI & Design Transfer Partner early with Engineering and Quality so new products are designed for manufacturability and scale from day one. Build a design-transfer process that lets LightForce innovate quickly without destabilizing production. Build a Lean, High-Performing Organization Install a practical Lean operating system - standard work, visual management, tiered reviews - sized right for a fast-scaling medtech company. Recruit, develop, and retain an exceptional Operations leadership team, with real succession depth and career pathways. Partner on Quality, Supply Chain & Financials Ensure Production operates in full compliance with FDA requirements, ISO 13485, and the LightForce Quality Management System - with quality built in, not inspected in. Own the Production and Technical Operations operating and capital budgets, and build the business cases behind major manufacturing investments. What You Bring 12+ years of progressive manufacturing and operations leadership, including significant experience in an FDA-regulated medical-device environment. A track record of scaling a manufacturing organization through a major step-change in volume and complexity - you've done this before. Deep knowledge of FDA Quality System requirements, ISO 13485, process validation, design transfer, and manufacturing controls. Hands-on experience with Lean manufacturing, automation, and process engineering - and the financial fluency to manage significant CapEx/OpEx budgets. Bachelor's degree required; technical degree preferred. Who Thrives Here We're looking for a builder, not a caretaker. The right person is as comfortable setting a three-year manufacturing strategy as they are standing on the production floor diagnosing a process problem. You build strong teams rather than becoming the person who personally solves every issue. You bring structure and discipline without bureaucracy, move well across Engineering, Quality, Supply Chain, and Commercial, and combine urgency with good judgment - even when the information is incomplete. Unlimited PTO for exempt employees (accrued PTO for non-exempt employees, up to 15 days) 12 paid holidays per year, plus 3 paid volunteer days Generous premium coverage for medical, dental, and vision 401(k) retirement plan and paid parental leave Fringe lifestyle benefit, plus everyday perks like snacks and coffee in office To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liabilities. LightForce Orthodontics is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. #J-18808-Ljbffr LightForce