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Senior QA Engineer

Remote: 
Full Remote
Contract: 
Full time
Work from: 
Republic of Lithuania, Poland, Portugal, Sweden, Germany, France

Offer summary

Qualifications:

Proven experience in Quality Assurance within the Medical Device industry, preferably in leadership roles., Deep understanding of QMS principles and successful implementation track record., Strong background in risk management, Agile methodologies, and medical device development., Exceptional problem-solving, analytical, and communication skills, especially in a remote-first culture..

Key responsabilities:

  • Lead Quality & Compliance Initiatives by managing and validating QMS systems and automating software testing.
  • Plan, execute, and refine processes related to customer feedback, complaints, and software defects.
  • Collaborate with engineering, manufacturing, and operations teams to ensure quality is embedded throughout processes.
  • Contribute as a QA stakeholder in medical device software development, focusing on design controls and risk management.

Neko Health logo
Neko Health Startup https://www.nekohealth.com/
11 - 50 Employees
See all jobs

Job description

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.

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.

    • Why Join Us?
  • Make a Real Impact – Your work will directly influence the quality and safety of medical devices used worldwide.
  • Work on Exciting Challenges – Tackle complex problems in exciting, fast-evolving industry of preventive health.
  • Grow & Innovate – Be part of a forward-thinking team that values continuous learning, experimentation, and smart automation.
    • About the Engineering Team

    Distributed and Remote First
    We are nearly 100 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. We don't expect people to join us with a specific tech knowledge, but we do expect you to work with our tools. We use a mix of React, Typescript, C++, and Python. Our APIs are written in C# with ASP.NET Core, uses Azure Cosmos DB, and Azure Active Directory for authentication. 

    Our headquarters and our hardware development team are in Stockholm, Sweden.

    We are a Remote First company; 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 Working
    The 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.

    Required profile

    Experience

    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Other Skills

    • Adaptability
    • Communication
    Are you interested?

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