About the Role
Location: Stockholm, Sweden
At Neko Health, we are developing innovative medical technologies that enhance healthcare outcomes. 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 production, engineering, and suppliers to ensure process validation, record integrity, and ongoing compliance with ISO 13485, EU MDR, and good manufacturing practices.
Responsibilities:
- Ensure manufacturing and installation activities comply with approved procedures and regulatory standards.
- Review and approve manufacturing changes such as procedures, work instructions, and test protocols.
- Plan and execute process validations in collaboration with engineering and other stakeholders.
- Review and approve manufacturing records, including:
- Incoming inspection results
- Equipment qualification and calibration
- Labeling, packaging, and transport tests
- In-process and final inspections
- Nonconformance investigations
- Installation test records and device release
- Conduct supplier assessments andaudits, and monitor supplier performance.
- Support nonconformance investigations and CAPAs, ensuring proper root cause analysis and resolution.
- Oversee MES data integrity and traceability, supporting improvements and validation as needed.
- Drive continuous improvement in quality processes, systems, and documentation.
Requirements:
- BSc or MSc in engineering, life sciences, or a related field.
- 5+ years’ experience in QA roles within 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.
- Experienced 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 mindset.
At Neko Health, you’ll be part of a team driving high-quality, compliant manufacturing of next-generation medical technologies. If you're passionate about quality, process validation, and continuous improvement, we’d love to hear from you!
About the Engineering Team
Distributed and Remote FirstWe 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 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.
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