Head of Quality

Role: Head of Quality Location: Cambridge, MA - in-person strongly preferred About Lambda Surgical Lambda Surgical is building physical intelligence for surgery. As more procedures move to camera-based approaches, surgeons increasingly operate from a 2D projection rather than a true spatial understanding of the operative field. Our first product, LambdaGuide, is a LiDAR-based spatial measurement system designed to integrate into existing endoscopic and robotic workflows and improve intraoperative precision. Pending FDA clearance, LambdaGuide has the potential to dramatically change how surgeons measure, navigate, and make decisions inside the body. Backed by some of the world’s leading technology investors, Lambda is building toward a future in which surgery is more precise, more intelligent, and more autonomous. Ultimately, we believe LambdaGuide will become the foundation for autonomous surgery by enabling the same core capability that unlocked autonomy in robotics: an adaptive world model that learns from expert human operators. Role Overview We are hiring a Head of Quality to build and run the quality and operational backbone of Lambda Surgical. This person will own our QMS, design assurance, submission evidence, audit readiness, and day-to-day execution of quality processes. The role is both strategic and hands-on: you will help us build the system, make sure it is used correctly, and ensure the company can develop, test, release, install, service, and document medical devices in a disciplined and audit-ready way. This is not a paper-quality role. We need a practical operator who can make quality real. Responsibilities Own and mature Lambda's QMS, including SOPs, templates, training, document control, records, and audit readiness. Lead readiness for 21 CFR 820 / QMSR and ISO 13485 milestones. Own design assurance, including design controls, DHF structure, requirements, risk links, V&V traceability, protocols, reports, and submission evidence completeness. Ensure SOPs are executed, not just written. Create and manage role-based training plans; distribute, track, and document required trainings. Ensure clinical study personnel are trained on relevant clinical, device-use, and data-handling SOPs. Own operational quality processes including incoming inspection, supplier records, equipment records, calibration records, nonconformances, release records, product release checklists, installation checklists, and service records. Partner with engineering to ensure technical evidence, release criteria, and acceptance records are complete and credible. Ideal Background 3-5+ years in medical device quality, design assurance, quality systems, or quality operations. Experience building or scaling a QMS in a startup or small medtech company. Strong knowledge of 21 CFR 820, ISO 13485, design controls, document control, training, supplier quality, incoming inspection, CAPA/nonconformance, and product release. Technical enough to understand engineering evidence, software/hardware release records, requirements, risk, and V&V. Operational enough to chase details, close loops, run checklists, and make the system actually work. Traits We Value Utmost integrity. We need people who are honest, rigorous, trustworthy, and guided by a strong moral backbone and a genuine desire to do good with their time on earth. We value people who surface the truth quickly, even when it is inconvenient or difficult. High agency. We need people who take ownership, figure things out, create structure where it is missing, and drive ambiguous problems to resolution. Clear communication. We need people who can communicate clearly, directly, and thoughtfully across functions, including engineering, clinical, quality/regulatory, operations, leadership, partners, and customers. Other traits we value: curiosity, first-principles thinking, practical judgment, attention to detail, comfort with ambiguity, low ego, urgency, and excitement to build foundational technology for the future of surgery. #J-18808-Ljbffr Socket.dev