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.

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.

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.

About Until

What You'd Do

Responsibilities

• 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.

Requirements

• 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

• 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.

Benefits

• Access to a 401(k) retirement savings plan
• FSA and commuter benefits
• Daily lunch and dinners, plus a variety of snacks
• Monthly learning stipend
• On-site fitness center
• Quarterly team social budget