About the role
About the Role Location: Remote or Hybrid Are you passionate about shaping the future of medical technology? Do you thrive in a dynamic environment where quality, innovation, and automation intersect? We are looking for Senior QA Engineers to join our distributed team at Neko and play a pivotal role in ensuring the best in class quality management across our products and services. This is more than just a QA role – it's an opportunity to drive meaningful improvements in medical device quality, work on cutting-edge projects, and help shape our data-driven approach to quality management. If you're an experienced QA professional with a strong background in automation, data management, and regulatory compliance, we'd love to hear from you! Responsibilities: Lead Quality & Compliance Initiatives – Manage and validate QMS systems, automate software testing, and drive continuous quality improvements across our organization. Excellence in Quality Operations – Plan, execute, and refine processes and initiatives related to customer feedback, complaints, nonconformities, software defects, CAPAs, KPIs, and post-market surveillance. Collaborate Across Teams – Work closely with engineering, manufacturing and operations teams to ensure quality is embedded throughout our processes. Support Cutting-Edge Development – Contribute as a QA stakeholder in medical device software and instrument development, focusing on design controls and risk management. Champion Data-Driven Quality – Leverage automation, data analytics, and process optimization to enhance our Quality Management System. Requirements: Proven experience in Quality Assurance within the Medical Device industry, preferably in a leadership roles. Deep understanding of QMS principles and a track record of successful implementation. Strong background in risk management, Agile methodologies, and medical device development and/or manufacturing. Hands-on experience with automation, data management, and continuous improvement initiatives across various domains. Exceptional problem-solving, analytical, and communication skills – especially important in our remote-first culture. A pragmatic product-focused mindset, with in-depth understanding of medical device lifecycle. Knowledgeable in international regulations and standards such as EU MDR, FDA QSR, ISO 13485, IEC 62304, IEC 62366, and ISO 14971.
About the company
Neko Health is a Swedish health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Our vision is to create a healthcare system that can help people stay healthy through preventive measures and early detection. Neko has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is both convenient and affordable for the public. This requires completely reimagining the healthcare experience and incorporating the latest advances in sensors and AI. We are a remote first company, but the company is based in Stockholm and has over 200 employees across Europe.
