What are the responsibilities and job description for the Quality Assurance (QA) Specialist position at Until?
About Us
Until is a moonshot company building a pause button for biology. We believe this will unlock medical hibernation, deep space exploration, and fundamentally change humanity's relationship with the future.
One of the key outstanding challenges in the field has been the rewarming problem: how do we rapidly and uniformly rewarm large samples to press play on cryopreserved biology? One of the key ingredients is building N-of-1 electrical systems. Doing so requires a fast-paced, scrappy team of electrical engineers and physicists who want to make technology indistinguishable from magic.
Key Responsibilities
Until is a moonshot company building a pause button for biology. We believe this will unlock medical hibernation, deep space exploration, and fundamentally change humanity's relationship with the future.
One of the key outstanding challenges in the field has been the rewarming problem: how do we rapidly and uniformly rewarm large samples to press play on cryopreserved biology? One of the key ingredients is building N-of-1 electrical systems. Doing so requires a fast-paced, scrappy team of electrical engineers and physicists who want to make technology indistinguishable from magic.
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
- 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
Salary : $40 - $50
