Join us at Qidni Labs! Were on a mission to revolutionize kidney failure treatment by developing the worlds most accessible dialysis technology. If youre passionate about improving lives through innovation and have expertise in Quality Assurance for medical devices , we want to hear from you! Company Description Qidni Labs Inc. is a clinical-stage medical device company dedicated to revolutionizing kidney failure treatment. Our mission is to develop the worlds most accessible dialysis technology to help millions of patients living with kidney failure. Role Description We are seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our team in Kitchener, ON . This is a full-time, on-site position. In this role, you will provide essential Quality and Regulatory support across the organization, lead quality initiatives, organize training, and ensure compliance with international medical device standards. You will play a key role in fostering a strong quality culture within Qidni Labs. Essential Duties and Responsibilities Lead and coordinate all quality activities and initiatives, ensuring compliance with medical device regulatory requirements, including ISO 13485, FDA, Health Canada and CE marking regulations Champion a strong quality culture across the organization by promoting best practices and acting as a bridge between the QA function and cross-functional teams Oversee the maintenance and continuous improvement of the Quality Management System (QMS) Collaborate with research and product development teams to improve product quality, including risk management throughout the product life cycle Perform other related duties as assigned Qualifications Education & Experience Bachelors degree in Science, Engineering, or a related field (required) Minimum of 5 years of experience in the medical device industry, with proven success in cross-functional team environments Skills Strong knowledge of ISO 13485, FDA, and Health Canada QMS requirements for medical devices In-depth knowledge and/or formal training in quality principles and tools (QMS, DOE, Design for Six Sigma, and related methodologies) Strong project management, problem-solving, and change management skills Dynamic, self-driven, and able to work both independently and collaboratively in a team environment Excellent oral and written communication skills Proficient in Microsoft Office and other business-related software Preferred Graduate degree (Masters or PhD) Engineering background in electronics, mechanical, or software disciplines We are an equal opportunities employer and welcome applications from all qualified candidates. #J-18808-Ljbffr
Job Title
Quality Assurance Engineer