Qidni Labs Inc. is a clinical-stage medical device company focused on transforming dialysis for people living with kidney failure. The team is developing highly accessible, portable dialysis technology that is nearly waterless and can be fully powered by rechargeable batteries. By removing the need for traditional dialysis infrastructure, Qidni Labs aims to make life-saving treatment available to patients across diverse settings worldwide. The company’s blood dialysis technology is designed for use in rural areas, natural disasters, emergency situations, battlefields, and satellite dialysis units where current options are limited. Joining Qidni Labs means contributing to innovative solutions that can improve care and quality of life for millions of patients.

Role Description

We are seeking an experienced, hands-on Quality Lead to take responsibility for Quality across the full product lifecycle. You will lead cross-functional quality activities, and be actively involved in execution. You will also contribute to regulatory submissions and help build the quality processes and capabilities needed to support Qidni’s growth and commercialization. This role works closely with engineering, software, clinical, product, manufacturing,



and regulatory functions and is responsible for fostering a strong quality culture across the organization.

Essential Duties and Responsibilities Quality Leadership & Quality Management System

- Lead, coordinate, and execute on Quality activities and initiatives across the organization, ensuring compliance with applicable medical-device requirements, including ISO 13485 and MDSAP requirements, applicable CE marking requirements, and other jurisdictional requirements.
- Own, maintain, and continuously improve the Quality Management System (QMS).
- Champion a solid quality culture by promoting practical best practices and providing Quality leadership.
- Identify Quality priorities, drive activities to completion, and build scalable quality processes and capabilities to support company growth.
- Coordinate with external quality experts as appropriate.
- Ensure design controls are effectively implemented and Design and Development Files are generated and maintained.
- Partner with cross-functional teams on user needs, risk management, design inputs and outputs, verification and validation, traceability, design reviews, product changes and design

📌 Quality Lead (Kitchener)
🏢 Qidni Labs
📍 Kitchener