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LightForce is transforming orthodontics through a fully digital, 3D-printed platform that replaces traditional brackets with customized, patient-specific solutions paired with AI-driven treatment planning. The company is seeking a VP of Quality & Regulatory to build and scale the organization, systems, and culture needed for the next stage of commercial growth.
This is an executive leadership role with real influence over product strategy and company operations. You will not be a gatekeeper but rather a strategic partner who embeds quality and regulatory thinking into product development from the start. You'll report to senior leadership and participate on the Executive Leadership Team as the company's senior voice on product quality, patient safety, and regulatory strategy.
Key responsibilities include:
**Quality Management System**: Strengthen and scale the QMS in line with FDA requirements and ISO 13485 standards. Establish sustained audit and inspection readiness with management reviews that drive actual business decisions.
**Process Quality**: Build strong process quality capability with Operations, including process control, statistical process control (SPC), validation (IQ/OQ/PQ), and quality-at-the-source practices. Use data and trend analysis to shift from inspection toward prevention.
**Root-Cause Discipline**: Own the nonconformance and CAPA systems with rigorous investigation and closed-loop learning that feeds back into design, process, and training.
**Design & Software Quality**: Partner with Product, Hardware, Software, and Clinical teams throughout development on design controls, DHFs, verification/validation, and risk management.
**Regulatory Strategy**: Set global regulatory strategy, lead FDA submissions and filings, and serve as senior company representative with regulatory authorities.
**Organization Building**: Recruit and develop leaders and specialists across Quality Engineering, Regulatory, Supplier Quality, and Complaints/CAPA. Build executive dashboards and report performance and risk to the ELT and Board.
You will bring 12+ years of progressive quality leadership in regulated medical devices, with significant commercial-manufacturing responsibility and at least 5 years leading a substantial Quality organization. Deep knowledge of FDA medical device regulations, ISO 13485, design controls, and DHR/DMR systems is essential. Experience with digital health, software-as-a-medical-device (SaMD), or 3D printing/additive manufacturing is a plus.
