Senior QA Engineer

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 almost 100 employees across Europe.About the RoleWe are seeking a skilled and experienced Senior QA Engineer to join our dynamic and distributed team. As a Senior QA Engineer at Neko, you will play a crucial role in ensuring the highest quality of our products and services across various domains. You will be responsible for managing and validating systems, as well as automating quality processes.In this role, you will work on diverse tasks with different stakeholders, ranging from handling customer complaints to contributing to product development and process improvements. Our data-driven QMS approach requires you to have experience in data management and automation to be successful. You will plan, lead, and execute quality management initiatives, including feedback and complaints, nonconformities, software defects, CAPAs, KPIs, and PMS.Responsibilities:Manage and validate QMS systems and software system test automationPlan, lead, and execute quality projects and data initiatives, including feedback and complaints, nonconformities, software defects, CAPAs, KPIs, and PMSCollaborate with stakeholders and system owners to drive quality improvementsSupport medical device instrument and software development projects as QA stakeholder, focusing on design controls and risk managementEnsure compliance with international regulations and standardsRequirements:Established commercial experience in Quality Assurance roles within the Medical Device industry, preferably in a management positionDeep understanding of Quality Management System principles and effective implementationDemonstrated success in project delivery and technical writingStrong background in risk management and Agile software development lifecycle processesExceptional analytical and problem-solving skillsEffective communication and teamwork abilities, essential for our remote-first environmentExtensive experience from driving continuous improvement efforts, preferably with multiple stakeholder groupsA product mindset, with a keen understanding of user needs and product lifecycleComprehensive understanding of international regulations and standards e.g. EU MDR, FDA QSR, ISO 13485, IEC 62304, IEC 62366, and ISO 14971)About the Engineering TeamDistributed and Remote FirstWe are 40 full time engineers at the company, working from Berlin, Chamonix, Hamburg, Lisbon, Marseille, Vilnius, and Stockholm, spanning diverse disciplines such as Hardware Engineering, Firmware Development, Electrical Design, Algorithm Development, Machine Learning Development, Optronics Research, Frontend Development and more.Our headquarters and our hardware development team are in Stockholm, Sweden.We are aRemote Firstcompany; however, it is of course much easier to work remotely as a software engineer than a hardware or firmware engineer (since they require access to hardware or devices occasionally). Software engineers based in Stockholm work maybe one day a week or one day every two weeks from the office.We meet a couple of times per year to get to know each other and have fun.Organization and Way of WorkingThe engineering team is divided into smaller cross functional project teams that each focus on a specific goal or target, where some groups are long-lived, and some are short-lived, depending on how big the goal or deliverable is. We strive to create groups which are cross-functional and able to complete their goals without dependence on other teams, even though this is of course not always possible.Groups track goals on a yearly and quarterly basis with goal follow-up across the entire engineering organization on a bi-weekly basis. Most groups do internal planning on a bi-weekly basis, but in the end it's up to the group to decide how they want to work.We have, however, mandated that all groups must present their progress or failures or hacks at our bi-weekly engineering demo, a fun meeting/presentation where we talk about everything from short-circuiting power-modules, how hard it is to calibrate cameras or align polygons in space, to neat new command line tools for operations, a new auth mechanism in the backend, a cool new way to visualize health data or a new feature which helps our doctors be more productive.We have a flexible workplace that focuses on work/life balance, and we strongly believe in our mission but do not think that achieving it requires sacrificing everything else. #J-18808-Ljbffr