Eli Lilly and Company
Quality Assurance and Regulatory Affairs Manager
Montreal (in-person) · Mid
Sponsorship not specifiedDetected 36 days ago
Intellectual PropertyCadenceFDA RegulatoryMedical DevicesRegulatory Affairs
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odds of building a lasting career here
42Risky
Cap-exempt (no lottery)0
Sponsors this role100
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
Thin sponsorship signal and lottery-bound. A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card follow-through: 79%
Of 14 labor certifications old enough to have been used, 3 expired without the employer filing the next step. Median time from filing to decision: 476 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
59 transfer filings in the last year, covering 59 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- 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:
Responsibilities
- 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.
- Eli is looking for a QA/RA Manager to own our quality management system end-to-end.
- Own and run the core QMS processes on a defined cadence: document control, change control, non-conformances, CAPA, training records, and equipment management.
- 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 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 are organized enough to maintain a cadence when nobody is checking, and you say so plainly when something slips.
- You'll be part of the core team developing and commercializing the first product that monitors hormonal data daily and over a lifetime.
Requirements
- 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 have the software skills to work in an electronic quality system, and enough technical curiosity to sit with engineers and scientists.
- 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.
Benefits
- 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'll work with a group of talented and mission-driven people eager to improve lifelong health at scale.
- You'll get health insurance (medical, dental, vision, and more) to ensure you and your family stay physically and mentally at your best.
- We look forward to learning about you!
Company info
- 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.
- 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.
- We are looking for someone who wants to own a quality system, not administer one corner of someone else's.
- 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.
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This listing is sourced directly from Eli Lilly and Company's careers page and normalized into a canonical job model.