About the roleEli is looking for a QA/RA Manager to own our quality management system end-to-end. Eli's QMS is built to comply with FDA 21 CFR Part 820: running and updating core processes, keeping the system audit-ready, and making quality work at the pace of a company bringing a novel diagnostic to market. You will work closely with manufacturing and regulatory. Your primary responsibilities will be to:
- Own and run the core QMS processes on a defined cadence: document control, change control, non-conformances, CAPA, training records, and equipment management.
- Maintain and improve our electronic QMS while keeping it practical for the teams who use it daily.
- Keep design and production documentation up to date as the product evolves, including the Design History File and Device Master Record.
- Own supplier qualification and supplier quality - audits, agreements, and documentation.
- Support internal audits and coordinate Eli through external audits.
- Train new and existing employees on the QMS and applicable regulations, and follow through until records are complete.
- Work with the CTO to define, communicate, and meet quality policies and objectives.
This description is not exhaustive. We are looking for someone who wants to own a quality system, not administer one corner of someone else's.
About you- You have 3-5 years of QA/RA experience in medical devices, diagnostics, or another regulated industry where records are part of the work rather than paperwork after it.
- You think about regulation from first principles. You go back to what a standard actually requires and why, rather than reproducing the system you used elsewhere. You can tell the difference between what compliance genuinely demands and what habit has layered on top, and you build the lightest system that fully meets the requirement.
- You have personally maintained records that someone later reviewed or audited. You have done the filing and chased the signatures, not only read the procedures.
- You are rigorous and thorough in your documentation, and you are willing to be the one to say a record is incomplete.
- You are organized enough to maintain a cadence when nobody is checking, and you say so plainly when something slips.
- You can read a procedure and follow it precisely, and you ask when something is unclear rather than guessing.
- You have the software skills to work in an electronic quality system, and enough technical curiosity to sit with engineers and scientists.
- You communicate clearly in writing and in person, and you work across teams without needing authority to get cooperation.
- You have a Bachelor's degree in Engineering, Science, or a related field.
- (Advantage) You have worked with a physical consumable, a reagent, or a laboratory supply chain.
If you don't exactly match the description but still believe you are the right person to join the team, please reach out. We value mindset and character.
How to applySounds like you? Please apply using this link:https://jobs.ashbyhq.com/eli. Please note that we will not review applications made through other platforms. We look forward to learning about you!
