Quality Lead

Quality Lead (QMS Owner) 16 Bit Inc. | Toronto, ON | Remote (GTA preferred) About 16 Bit 16 Bit's mission is to create trusted medical AI software that reveals hidden information to enable smarter care, seamlessly and at scale. Our flagship product, Rho, is the world's first AI of its kind to be authorized by Health Canada, FDA, EU, TGA, and HSA for opportunistic screening of osteopenia and osteoporosis from routine x-rays. Rho has already screened over 650,000 Canadians, with the live count visible on our website. Our team is small by design. It includes founding radiologists with computer science and engineering backgrounds, senior engineering talent, and a research and regulatory lead who drives our publications and clearances. We are profitable, we ship deliberately, and we use AI extensively to stay lean. We hold each other to a high standard. We are looking for someone who meets or exceeds it. The role Our QMS is currently document-heavy and managed largely in Google Drive and FormWork. It is functional, but it creates drag on the team and pulls our research and regulatory lead away from the publication and clearance work where she contributes most. We are hiring a Quality Lead to take full ownership of quality at 16 Bit and modernize our QMS into a system that supports the pace at which we operate. This is a critical hire. The right person will set the standard for clinical and regulatory rigour across the company while building a system that makes that rigour easier to maintain. What you will own Quality Management System. Primary ownership of our ISO 13485, QMSR, EU MDR, and MDSAP-aligned QMS. Document control, training, CAPA, supplier qualification, risk management under ISO 14971, post-market surveillance (complaint handling, adverse event reporting, post-market clinical follow-up, periodic safety reviews), and continuous audit readiness for notified bodies, FDA inspectors, Health Canada, and partner due diligence. You will plan and run management reviews, tracking quality objectives, report on QMS health, and lead and host internal and external audits. QMS modernization. Lead the transition from our current document-based system to a more efficient model. This may be a commercial eQMS platform, an internal pipeline built around tools like Jira and AI agents, or a hybrid of both. Scope the project, evaluate the options, run the migration, and bring the team along. This is a Year 1 priority and a defining contribution. Quality readiness for new markets. Develop quality plans for entering new markets, understanding jurisdiction-specific requirements for postmarket surveillance, labeling, etc. Quality partnership with engineering and research. Integrate design controls and software lifecycle management under IEC 62304 into how the team builds, rather than bolting them on at the end. What may grow into the role 16 Bit is small and our scope flexes. There are real gaps where the right person could expand their contribution over time: Operations: vendor management, contract administration (i.e. BAAs), and broader connective tissue. Customer success and deployment operations: install coordination and partner onboarding. We are not asking for fluency in all of these. We are asking for someone who is curious, willing to learn, and comfortable with a role that will evolve. What we are looking for 3 to 10+ years in quality and regulatory roles in medical devices, ideally SaMD or digital health. Direct, hands-on experience with ISO 13485, QMSR, EU MDR, ISO 14971, IEC 62304, and MDSAP, training certifications are an asset. Demonstrated end-to-end ownership of a QMS, not partial contribution to one Experience implementing or migrating to an eQMS platform is a significant asset Comfort moving between high-level planning and hands-on execution. There is no one to delegate the small tasks to. Clear, direct writing. SOPs, customer-facing email, and Slack replies handled with the same care. Someone detail-oriented, self-motivated and disciplined to produce exceptional quality work in a remote work environment. Genuine alignment with the mission. We are identifying patients who would otherwise be missed. What we do not require Complete coverage of every standard listed above. If you have owned a QMS for a SaMD product and learned quickly, we will support the rest. Marketing or communications experience. The role can grow in that direction if you are interested, but it is not required. Logistics Location. Fully remote. We are Toronto-based and prefer candidates in the GTA so you can join us for company socials and occasional in-person working sessions. We are open to outstanding candidates elsewhere. Compensation. Competitive base and meaningful equity with benefits. Specific ranges are based on the qualifications of the candidate. Timeline. We are not in a hurry. We are looking for the right person, not the fastest hire. Expect a thorough process focused on technical depth and cultural alignment. Our values These are the values we use when making decisions: Quality. We hold ourselves to the highest standard in clinical data, product design, and user experience. Innovation. We lead through medical and technical excellence to chart a path toward a better future for patients. Elegance. We leverage deep healthcare knowledge to create simple and effective solutions. Trust. We earn trust through integrity, reliability, and sound evidence. If those resonate, we would like to hear from you. How to apply Send a short note about why this role interests you and why you are a great fit, along with your CV and LinkedIn, to [email protected].

The Quality Lead will take full ownership of the Quality Management System (QMS) and modernize it to support the company's operational pace. This includes managing document control, training, CAPA, supplier qualification, and ensuring quality readiness for new markets.

Candidates should have 3 to 10+ years of experience in quality and regulatory roles in medical devices, with hands-on experience in relevant standards. Strong communication skills and a detail-oriented approach are essential, along with a genuine alignment with the company's mission.

• Health Insurance • Stock Options

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Quality Management System
• ISO 13485
• QMSR
• EU MDR
• ISO 14971
• IEC 62304
• MDSAP
• Document Control
• Training
• CAPA
• Risk Management
• Post-Market Surveillance
• Audit Readiness
• eQMS
• Design Controls
• Software Lifecycle Management

• Healthcare
• Technology
• Management & Leadership
• Science & Research
• Software

Expérience minimale

10+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Mid-Senior level

Mode de candidature

La candidature directe est offerte