Company Description
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 strong 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.
Product Development & Risk Management
- 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 transfer activities.
- Work closely with engineering, software, clinical, and product teams to integrate Quality throughout product development.
Regulatory
- Contribute to regulatory strategy, identification of applicable standards, testing requirements, and supporting evidence for submissions.
- Support FDA and other regulatory authority interactions, including preparation of responses to regulatory questions.
- Coordinate with external regulatory experts as appropriate.
Manufacturing, Supplier Quality & Commercialization
- Lead Quality through design transfer, manufacturing readiness, and commercial launch.
- Develop and oversee supplier qualification and supplier-quality activities.
- Lead complaint handling, post-market quality, and other commercial quality activities as the company progresses toward commercialization.
Qualifications
Education & Experience - Required
- Bachelor’s degree in Science, Engineering, or a related field.
- 5+ years of medical-device Quality experience, with meaningful Regulatory experience.
- Direct experience supporting medical devices through regulatory submission and clearance.
- Experience taking a medical device from development through design transfer and commercial launch.
- Experience leading cross-functional quality activities while remaining a hands-on contributor.
Skills & Technical Experience - Required
- Strong knowledge of medical-device QMS requirements.
- Deep hands-on experience with implementing QMS.
- Strong project-management, problem-solving, decision-making, and change-management skills.
- Excellent oral and written communication skills, with the ability to influence and collaborate across technical and non-technical functions.
- Dynamic, pragmatic, self-driven, and able to work effectively both independently and collaboratively in an early-stage environment.
- Proficient in Microsoft Office and other business-related software.
Preferred Qualifications
- Engineering background in electronics, mechanical, software, or a related discipline.
- Experience with ISO 14971, IEC 62304, and IEC 60601.
- Experience working with contract manufacturers and/or critical suppliers.
- Direct experience interacting with regulatory authorities.
- Experience in an early-stage or startup medical-device company.
