MedTech Quality & Regulatory Leader for Scale

LightForce; Wilmington (MA); On-site; USD 230,000 - 330,000; Full time

Benefits offered by this job

Unlimited PTO

12 paid holidays

Premium medical, dental and vision

401(k) retirement plan and parental le

Job summary

LightForce Orthodontics is seeking a VP of Quality & Regulatory to build scalable systems that enable fast, safe growth. You will own the Quality Management System and shape global regulatory strategy across markets.

Partner with Product, Hardware, Software and Clinical teams, drive CAPA, root-cause investigations, and measurement dashboards for the ELT and Board. The role blends deep technical insight with executive influence to balance speed and patient safety.

Qualifications

• 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.
• 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.

Responsibilities

• Own the Quality Management System
• Lead Process Quality
• Drive Root-Cause Discipline
• Champion Design & Software Quality
• Own Regulatory Strategy & Execution
• Build the Organization

Skills

Leadership

Quality systems

Regulatory strategy

Education

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

Job description

LightForce Orthodontics is seeking a VP of Quality & Regulatory to build scalable systems that enable fast, safe growth. You will own the Quality Management System and shape global regulatory strategy across markets.

Partner with Product, Hardware, Software and Clinical teams, drive CAPA, root-cause investigations, and measurement dashboards for the ELT and Board. The role blends deep technical insight with executive influence to balance speed and patient safety.