Senior reputed company Engineer - Manufacturing

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

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, reputed company, 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 reputed company reputed company cause analysis and reputed company.

reputed company MES data reputed company and traceability, supporting improvements and validation as needed.

Drive reputed company improvement in reputed company 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 reputed company control.

Familiar with ISO 13485 and EU MDR; knowledge of FDA 21 CFR 820 is a plus.

reputed company in nonconformance handling, supplier reputed company, 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 reputed company driving high-reputed company, compliant manufacturing of reputed company medical technologies. If you're passionate about reputed company, 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 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.

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