Quality Assurance Manager MDR / ISO13485

Company DescriptionCuravista is an award-winning, innovative, and cost-effective healthcare ICT company. It develops www.curavista.health and Gezondheidsmeter.nl, which serve as personal health records. With experience across various fields such as asthma, COPD, diabetes, hypertension, and rare diseases, Curavista's services are available in 11 languages and cater to over 400,000 patients and their healthcare professionals.Role DescriptionThis is a full-time hybrid role for a Quality Assurance Manager MDR/ISO13485 based in Raamsdonksveer, with some opportunities to work from home. The Quality Assurance Manager will be responsible for overseeing and maintaining compliance with MDR and ISO13485 standards, conducting audits, managing quality assurance processes, and ensuring the highest levels of regulatory compliance and product quality. The manager will also collaborate closely with cross-functional teams to implement quality strategies and improvement plans.QualificationsExperience with MDR and ISO13485 standardsProficiency in quality assurance processes, audits, and regulatory complianceStrong analytical, problem-solving, and decision-making skillsExcellent written and verbal communication skillsAbility to work independently as well as within cross-functional teamsExperience in the healthcare industryExperience with MDR audits and contact with the Notifiy BodyBachelor's degree in a related field such as Quality Management, Health Sciences, or equivalent