QA/RA Manager: Own the QMS for Med Devices

Eli Health; Montreal; On-site; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Spa access in Montreal

Job summary

Eli Health is hiring a QA/RA Manager to own the quality management system end-to-end, ensuring regulatory alignment with FDA 21 CFR Part 820 and a product-ready QMS. You will partner with manufacturing and R&D to keep documentation current and auditable.

Your work will span document control, supplier quality, and internal/external audits, with emphasis on cross‑functional teamwork and proactive quality leadership across the Montreal operation.

Qualifications

• 3–5 years of QA/RA experience in medical devices or regulated settings.
• Regulatory requirements understood from first principles, not rote copying.
• Maintained records for audits and ensured signatures were captured.
• Rigorous documentation and ability to declare incomplete records.
• Organized cadence in absence of oversight and clear when something slips.
• Read and follow procedures precisely; seek clarification when needed.
• Software skills to operate an electronic quality system with engineers/scientists.
• Clear written and verbal communication; cross-team collaboration without authority.
• Bachelor’s degree in Engineering, Science, or related field.
• Advantage: experience with consumables, reagents, or lab supply chains.

Responsibilities

• Own and run the core QMS processes end-to-end: document control, change control, non-conformances, CAPA, training records, equipment management.
• Maintain and improve the electronic QMS for day-to-day use by teams.
• Keep design history file and device master record up to date with product evolution.
• Own supplier qualification and supplier quality: audits, agreements, documentation.
• Support internal audits and coordinate with external audits.
• Train new and existing employees on QMS and regulations; ensure records are complete.
• Collaborate with the CTO to define, communicate, and meet quality policies and objectives.

Skills

QA/RA experience

Regulatory mindset

Documentation discipline

Audit readiness

CAPA management

Cross-functional collab

Engineering/Science degree

Education

Bachelor's degree in Engineering/Science

Tools

Electronic QMS

Job description

About us

Eli Health is making continuous hormone monitoring possible, helping users support their daily and long-term health. No more waiting days to track key biomarkers—get results you can use within minutes. Eli’s flagship product, Hormometer®, is the first instant hormone monitoring platform to deliver results from saliva to mobile app—anytime, anywhere.

Developed over six years of R&D, over 2,000 product iterations, and backed by a dozen patent-pending innovations, Eli’s award-winning platform turns hormones into measurable signals you can track and improve. Just as the thermometer and glucometer have transformed health for millions, Eli’s platform is poised to be the next major evolution in tracking changes in stress, endurance, sleep, and more.

About the role

Eli 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.

Why you’ll love working at Eli

• You’ll work with a group of talented and mission-driven people eager to improve lifelong health at scale.

• You’ll be part of the core team developing and commercializing the first product that monitors hormonal data daily and over a lifetime.

• You’ll own our quality system outright, early in your career, at a point where the decisions you make about how it works will still be in place years from now.

• You’ll be part of a small (<25 people), high-performing, and diverse team where everything you do results in tangible impact and shapes the company’s trajectory.

• You’ll be in an environment where people drive their own work, think creatively about open-ended problems, and solve them proactively.

• You’ll get health insurance (medical, dental, vision, and more) to ensure you and your family stay physically and mentally at your best.

• You’ll have flexibility over your schedule and vacations. We seek to hire great people, then give them the autonomy and space they need to achieve their goals.

• Although our office and R&D facilities are in Montreal, we have a distributed team. We prioritize asynchronous workflows and minimize meetings to focus on the work itself.

• You and your +1 will have unlimited free access to the Bota Bota spa in Montreal to recharge.

How to apply

Sounds 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!