Vice President of Quality & Regulatory

LightForce; Wilmington (DE); On-site; USD 230,000 - 340,000; Full time

Benefits offered by this job

Unlimited PTO for exempt employees (ac

Paid holidays and volunteer days

Premium health coverage (medical, dent

401(k) retirement plan and parental be

Fringe lifestyle benefit and snacks/咖啡

Job summary

LightForce is seeking a VP of Quality & Regulatory to build scalable systems and integrate quality from the start as we scale commercially. You will align with FDA/ISO 13485, lead regulatory strategy, and sit on the ELT driving patient safety and product quality.

You will develop the QMS, lead audits, and partner with Product, Hardware, Software, and Clinical teams to ensure robust design controls and risk management across all devices.

Qualifications

• 12+ years of progressive quality leadership in regulated medical devices (commercial manufacturing quality responsibility).
• At least 5 years leading a substantial Quality organization or major function.
• Deep knowledge of FDA medical-device requirements, ISO 13485, design controls and risk management.
• Track record leading FDA, Notified Body, and regulatory submissions for commercial devices.
• Demonstrated use of quality engineering and statistical methods to prevent problems.

Responsibilities

• Strengthen and scale the QMS in line with FDA requirements and ISO 13485.
• Establish audit readiness and management reviews that drive decisions.
• Build a strong process quality capability with operations and SPC.
• Own CAPA and nonconformance systems with rigorous root-cause investigation.
• Partner with Product, Hardware, Software, and Clinical on design controls and risk management.
• Set global regulatory strategy and lead submissions with authorities.
• Recruit and develop leaders across Quality Eng, Regulatory, Supplier Quality, and Complaints/CAPA.
• Build an executive quality dashboard reporting performance and risk to ELT and Board.

Skills

Leadership

Quality management

Regulatory strategy

Data-driven decisions

Education

Bachelor's or Master's degree in Engineering, Life Sciences, or related field

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 pragmatic and solutions-oriented, not bureaucratic - you understand that strong quality systems should create speed and confidence, not slow everyone down. You're technical enough to go deep, but you can explain complex quality and regulatory issues simply to executives, engineers, and the Board alike. You build systems and people rather than becoming the bottleneck yourself, and you're comfortable with ambiguity, incomplete information, and ambitious goals.

Compensation & Perks

• 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.