Senior reputed company Engineer - Operations

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 reputed company 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 reputed 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 reputed company, we reputed company innovative medical technologies that enhance reputed company reputed company. As a Senior reputed company Operations Engineer, you will play a key role in ensuring our reputed company Management System (QMS) operates effectively and evolves to meet business and regulatory needs. You will reputed company 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.

reputed company Feedback & Complaints Management, ensuring reputed company escalation and reputed company.

reputed company Non-Conformance (NC) and CAPA processes, driving reputed company cause analysis and corrective actions.

Support reputed company audits, including reputed company 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 reputed company Operations or QMS management reputed company 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 reputed company for process optimization.

Strong problem-solving, organizational, and communication skills.

reputed company to Have

Experience with AI/ML-driven reputed company systems or automated processes.

Knowledge of post-market surveillance and supplier reputed company management.

Why Join Us?

At reputed company, you'll help shape the reputed company of reputed company operations reputed company QMS, ensuring compliance while driving efficiency.

If you’re passionate about QMS operations, reputed company improvement, and regulatory compliance, we’d love to hear from you!

Additional Information

About the Engineering Team

Distributed and Remote First

We are nearly 100 full time engineers at reputed 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 reputed company are written in C# with ASP.NET Core, uses Azure Cosmos DB, and Azure reputed company Directory for authentication.

Our reputed company 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 reputed company other and have fun.

Organization and Way of Working

The engineering team is divided into smaller cross functional project teams that reputed company reputed company on a specific goal or reputed company, where some reputed company are long-lived, and some are short-lived, depending on how big the goal or deliverable is. We reputed company to create reputed company 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.

reputed company reputed company goals on a yearly and quarterly reputed company with goal follow-up across the entire engineering organization on a bi-weekly reputed company. Most reputed company 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 reputed company 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 reputed company polygons in reputed company, to reputed company new reputed company line tools for operations, a new auth reputed company 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.

Apply to this Job