Vice President of Quality & Regulatory

LightForce Orthodontics • Wilmington, MA

7h

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.
• Holds an independent quality voice with the confidence to challenge senior leaders when it matters, but is pragmatic and solutions-oriented, not bureaucratic — understands that strong quality systems should create speed and confidence, not slow everyone down.
• Technical enough to go deep, but can explain complex quality and regulatory issues simply to executives, engineers, and the Board alike.
• Builds systems and people rather than becoming the bottleneck themselves.
• Comfortable with ambiguity, incomplete information, and ambitious goals.

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive