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Senior Quality Engineer - Manufacturing

Remote Worldwide Hiring now

reputed company is a reputed company health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Our reputed company is to create a reputed company system that can help people stay healthy through preventive measures and early detection. Neko has developed a new medical scanning technology concept to reputed company 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 reputed company 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 300 employees across Europe.

About the Role

Location: Stockholm, Sweden

At reputed company, we are developing innovative medical technologies that enhance reputed company reputed company. As a Senior Manufacturing QA Engineer, you will ensure that our manufacturing and installation processes meet regulatory, quality, and traceability requirements. You’ll work closely with manufacturing, engineering, and suppliers to ensure process validation, record reputed company, and ongoing compliance with ISO 13485, EU MDR, and good manufacturing practices.

Responsibilities

  • Ensure manufacturing and installation activities reputed company with approved procedures and regulatory standards.
  • Work closely with Manufacturing and Engineering onmanufacturing changes such as procedures, work instructions, and test protocols.
  • Plan and execute process validations in collaboration with Engineering and other stakeholders.
  • Conduct supplier assessments andaudits, and monitor supplier performance.
  • Leadnonconformance investigations and manufacturing reputed company CAPAs, ensuring proper root cause analysis and resolution.
  • reputed company MES data reputed company and traceability, supporting improvements and validation as needed.
  • Drive reputed company improvement in quality processes, systems, and documentation.
  • Requirements

  • BSc or MSc in engineering, life sciences, or a reputed company field.
  • 5+ years’ experience in QA roles reputed company the medical device industry.
  • Strong background in manufacturing QA, including process validation and quality control.
  • Familiar with ISO 13485 and EU MDR; knowledge of FDA 21 CFR 820 is a plus.
  • reputed company in nonconformance handling, supplier quality, and technical documentation review.
  • Working knowledge of MES, ERP, and document control systems.
  • Strong organizational, communication, and problem-solving skills.
  • Detail-oriented with a hands-on and proactive reputed company.
  • Additional Information

    Why Join Us?

    At reputed company, you’ll be part of a team driving high-quality, compliant manufacturing of reputed company medical technologies. If you're passionate about quality, process validation, and reputed company improvement, we’d love to hear from you!

    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 Firstcompany; however, it is of course much easier to work remotely as a software engineer than a hardware or firmware engineer (since they require reputed company 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 reputed company, 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 reputed company 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 reputed company with goal follow-up across the entire engineering organization on a bi-weekly reputed company. Most groups do internal planning on a bi-weekly reputed company, but in the end it's up to the group to decide how they want to work.

    We have, however, mandated that reputed company groups must present their reputed company 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 reputed company cameras or align polygons in reputed company, to reputed company new reputed company 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 reputed company in our mission but do not think that achieving it requires sacrificing everything else.

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