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Eli Health is seeking a Quality Assurance and Regulatory Affairs Manager to own and operate the company's quality management system (QMS) end-to-end. Eli develops Hormometer®, the first instant hormone monitoring platform delivering saliva-based results to a mobile app within minutes, backed by six years of R&D and patent-pending innovations.
In this role, you will be responsible for building and maintaining a QMS compliant with FDA 21 CFR Part 820 while keeping it practical and audit-ready for a fast-moving medical device company. You will report to the CTO and work closely with manufacturing and regulatory teams.
Key responsibilities include:
- Owning and running core QMS processes on a defined cadence: document control, change control, non-conformances, CAPA, training records, and equipment management
- Maintaining and improving the electronic QMS to ensure it serves the teams who use it daily
- Keeping design and production documentation current as the product evolves, including the Design History File and Device Master Record
- Managing supplier qualification and supplier quality through audits, agreements, and documentation
- Supporting internal audits and coordinating external audits
- Training employees on the QMS and applicable regulations, with follow-through on record completion
- Defining, communicating, and meeting quality policies and objectives with the CTO
You will own the quality system outright, not administer a corner of someone else's. The company is small (<25 people), high-performing, and distributed, with the Montreal office serving as the hub for R&D and operations. You'll have tangible impact on the company's trajectory and shape how the quality system operates for years to come.
Requirements:
- 3–5 years of QA/RA experience in medical devices, diagnostics, or another regulated industry where records are integral to operations
- Ability to think about regulation from first principles, understanding what standards genuinely require versus what habit has added
- Personal experience maintaining records that were later reviewed or audited; hands-on filing and signature chasing
- Rigorous and thorough documentation skills; willingness to flag incomplete records
- Ability to maintain cadence independently and communicate transparently when something slips
- Ability to read and follow procedures precisely; asks for clarification rather than guessing
- Software skills to work in electronic quality systems and technical curiosity to engage with engineers and scientists
- Clear written and verbal communication; ability to work across teams without formal authority
- Bachelor's degree in Engineering, Science, or a related field
- Advantage: experience with physical consumables, reagents, or laboratory supply chains
The company values mindset and character; candidates who don't exactly match the description but believe they are the right fit are encouraged to apply.
