Quality Assurance and Regulatory Affairs Manager
Montreal (in-person)Full-timePosted 1mo ago
About the role
QA/RA Manager responsible for owning Eli Health's quality management system (QMS) end-to-end in a regulated medical device environment, ensuring FDA 21 CFR Part 820 compliance, and collaborating with manufacturing and regulatory functions.
Responsibilities
- 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.
Qualifications
- 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.
- Bachelor’s degree in Engineering, Science, or a related field.
- You have personally maintained records that someone later reviewed or audited.
- 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.
- Advantage: experience with a physical consumable, a reagent, or a laboratory supply chain.
Skills
Required:Quality Management System (QMS)Regulatory Knowledge (FDA 21 CFR Part 820)Electronic quality system softwareDocumentation and record-keeping
Benefits
- Health insurance (medical, dental, vision, and more)
- Flexible schedule and vacations
- Distributed team with asynchronous workflows
- Unlimited free access to Bota Bota spa for you and your +1
Last updated Sep 20, 2026. Interested? Apply on the company site.
About Eli Health
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