The Senior Quality Operations Engineer will manage quality systems, ensure compliance with regulations, oversee audits, and optimize workflows in medical technology.
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 300 employees across Europe.
About the Role
Location: Stockholm, Sweden or Europe | Full-time Remote or Hybrid
At Neko Health, we develop innovative medical technologies that enhance healthcare outcomes. As a Senior Quality Operations Engineer, you will play a key role in ensuring our Quality Management System (QMS) operates effectively and evolves to meet business and regulatory needs. You will oversee document and change control, feedback & complaints management, NC & CAPA, audits, training, and eQMS workflows, ensuring compliance with ISO 13485, EU MDR, and FDA regulations.
Responsibilities:
- Manage Document and Change Control, ensuring compliance and efficiency.
- Oversee Feedback & Complaints Management, ensuring timely escalation and resolution.
- Lead Non-Conformance (NC) and CAPA processes, driving root cause analysis and corrective actions.
- Support internal and external audits, including Notified Body and regulatory inspections.
- Manage Training Programs, ensuring employees meet competency requirements.
- Improve and optimize eQMS workflows to enhance usability and compliance.
Requirements:
- 5+ years of experience in Quality Operations or QMS management within the medical device industry.
- Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), and EU MDR.
- Experience managing Document Control, Change Control, Complaints, NC & CAPA, and Audits.
- Familiarity with Training Management systems and eQMS optimization.
- Hands-on experience with electronic QMS (eQMS) workflows, with a mindset for process optimization.
- Strong problem-solving, organizational, and communication skills.
- Experience with AI/ML-driven quality systems or automated processes.
- Knowledge of post-market surveillance and supplier quality management.
Nice to Have
Why Join Us?
- At Neko Health, you'll help shape the future of quality operations and digital QMS, ensuring compliance while driving efficiency.
- If you’re passionate about QMS operations, continuous improvement, and regulatory compliance, 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 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.
Top Skills
AI
Asp.Net Core
Azure Active Directory
Azure Cosmos Db
C#
C++
Electronic Qms (Eqms)
Eu Mdr
Fda Qsr
Iso 13485
Machine Learning
Python
React
Typescript
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