КанадаQuality Assurance and Regulatory Affairs Manager
1 мес. назад
КанадаSeniorOnsite
quality_management_systemdocument_controlchange_controlcorrective_and_preventive_actionsequipment_management
Manage and maintain the quality management system compliant with FDA regulations for a hormone monitoring platform.
О компании
- 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. ’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, ’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, ’s platform is poised to be the next major evolution in tracking changes in stress, endurance, sleep, and more.
Обязанности
- is looking for a QA/RA Manager to own our quality management system end-to-end. '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 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.
Требования
- 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.
Как откликнуться
- Sounds like you? Please apply using this link:. Please note that we will not review applications made through other platforms. We look forward to learning about you!
Другое
- 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.