Senior Quality Manager

Until is a moonshot company building a “pause button” for biology. Our near-term focus is organ-scale reversible cryopreservation: preserving donated organs at subzero temperatures without ice formation, then rewarming them uniformly for transplant. By solving this grand challenge, we’re laying the foundation for whole-body reversible cryopreservation, giving patients a bridge to future cures. As the company moves from research into productization and manufacturing, we are establishing a Quality function that lives inside the engineering work, not alongside it. We envision a future where no transplantable organ is lost to logistics, and no terminal diagnosis is final because patients can safely wait for future medicine to arrive. About the Role Until Labs is looking for a Senior Quality Manager to stand up and run the Quality function as the company moves toward manufacturing and its first regulatory submission. This is a player-coach role: you will own the Quality Management System and design quality day to day, working hands-on alongside the engineers and scientists building the product, while laying the groundwork for a growing quality team. You will help prepare the company for a regulatory journey that begins with an initial 510(k) and builds toward a Class III PMA and a combination-product profile. Just as important is how you do it. We are looking for a partner, not a policeman. The right person makes quality something teams want to work with because it helps them build better and move faster, and becomes the person R&D turns to for how to build it correctly the first time. This role is based in South San Francisco and operates on an onsite / hybrid basis. Why This Role Matters Quality at Until Labs is core to earning trust in a technology with profound clinical stakes. As Senior Quality Manager you will make sure the product is designed, documented, and proven to the highest standard, and build the systems and partnership-first culture that make quality a strength rather than a hurdle. What You'd Do • Own the day-to-day operation and continuous improvement of the Quality Management System, built to ISO 13485, 21 CFR 820 / QMSR, and ISO 14971 and scaled appropriately to the company’s stage. • Implement and manage design controls across the development lifecycle, working side by side with R&D and engineering on the design and development of the product. • Build and maintain Design History Files (DHFs), and own document control across design and quality records. • Drive design verification and validation (V&V) testing, including planning, protocol development, execution support, and reporting. • Lead risk management to ISO 14971, including hazard analysis, FMEAs, and risk documentation. • Embed human factors and usability engineering (IEC 62366) and software lifecycle practices (IEC 62304) into the design process. • Support design reviews and ensure design outputs trace cleanly to inputs and requirements. • Author, roll out, and maintain SOPs, and train teams on quality and the QMS so good practice is understood and owned across functions, not just enforced. • Run the internal and supplier audit program, and prepare for and support external, regulatory, and notified body audits. • Manage supplier quality, including qualification and monitoring, and bring external design and manufacturing partners’ records under Until Labs’ design controls. • Establish CAPA and complaint handling processes ahead of commercialization. • Support the 510(k) submission and help prepare the organization for the compliance requirements of a future Class III PMA and combination-product pathway. • Hire, mentor, and develop quality team members as the function grows. About You • Significant medical device quality experience (required). Candidates without a medical device background will not be a fit for this role. • Strong working knowledge of ISO 13485, 21 CFR 820 / QMSR, and ISO 14971. • Hands-on design quality experience, including design controls, DHFs, and design verification and validation. • Experience owning a Quality Management System, ideally including building out or substantially standing one up at an early-stage company. • Solid risk management experience, including FMEAs and hazard analysis, plus working knowledge of IEC 62366 and IEC 62304. • Experience authoring SOPs and conducting internal and supplier audits. • Experience with CAPA and complaint handling. • Experience supporting regulatory submissions, ideally a 510(k). • Experience leading organizations through MDSAP certification and recertification cycles. • Experience mentoring or managing quality staff, and an appetite to grow a team. • A technical mindset and the credibility to be the quality partner engineers actually want in the room, with the collaborative instinct to set standards without becoming a bottleneck. • Comfort working hands-on and with autonomy in an early-stage, fast-moving environment. Preferred Qualifications • Combination device and / or complex Class III electromechanical device experience. • Experience taking products through 510(k) and PMA pathways. • An engineering background. • Experience managing design records across external design and manufacturing partners. • Experience taking a novel or first-of-its-kind device from development toward manufacturing and submission. • Exposure to biologics-adjacent, tissue, or biological handling contexts.