Quality Assurance (QA) Specialist

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.

To achieve our goal, we are assembling an interdisciplinary team to develop perfusion systems, cryoprotectant formulations, and vitrification and rewarming hardware.

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.

Key Responsibilities

• Device History File (DHF): Maintain, organize, and update DHF in line with FDA design control requirements
• GLP Compliance: Monitor and support preclinical testing documentation to ensure GLP standards are followed
• ISO Compliance: Assist in implementation and documentation of ISO 13485, ISO 10993 (biocompatibility), ISO 11135/14937 (sterilization), ISO 11607 (packaging & shelf-life), IEC 62304 (software), and IEC 60601 (electrical safety/EMC)
• Validation & Testing Documentation: Support compilation and review of protocols and reports for biocompatibility testing (cytotoxicity, sensitization, hemocompatibility, etc.), sterilization and endotoxin validation, packaging and shelf-life studies, cleaning validation of reusable components, software verification & validation (IEC 62304), and human factors and usability testing
• Audit Readiness: Ensure documentation and records are inspection-ready for FDA and ISO audits
• Cross-Functional Support: Collaborate with regulatory consultants, R&D, and manufacturing partners to align quality documentation with IDE submission requirements
  
  
  
  
  

Qualifications

• Bachelor’s degree in life sciences, engineering, or related field
• 3–5+ years of experience in medical device quality assurance
• Strong knowledge of FDA regulations, GLP requirements, and ISO 13485 compliance
• Experience with Device History File (DHF), Design Controls, and Quality Management Systems (QMS)
• Excellent attention to detail and organizational skills
• Ability to work independently in a part-time, flexible schedule role
  
  
  
  
  

As an equal opportunity employer, Until is committed to providing employment opportunities to all individuals. All applicants for positions at Until will be treated without regard to race, color, ethnicity, religion, sex, gender, gender identity and expression, sexual orientation, national origin, disability, age, marital status, veteran status, pregnancy, or any other basis prohibited by applicable law.