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At Nicolab, we connect the physicians and streamline their emergency care workflows, providing physicians with AI-analyzed scans and centralized patient information. 

• Operational in 10+ countries across 4 continents. 

• Established presence in Europe and Australia. Quickly expanding to China, the Middle East, and the rest of Europe and Australia. 

• 30+ employees across the world, with our headquarters in Amsterdam.

Why We Need You

We started with a lean, stroke-focused product built entirely for GCP. Now we're expanding beyond stroke and beyond Google Cloud with an ambitious migration to a new cloud-agnostic, scalable platform. As we expand into new areas of healthcare, we've focused on creating an extensible platform that can easily adapt to new features and requirements. 

The Ideal Candidate 

We are looking for a Quality Engineer who will strengthen and maintain the quality of our product and related QMS processes, in accordance with the relevant standards and regulations, including but not limited to the European Medical Device Regulation (MDR), ISO 13485, ISO 14971 and ISO 62304. As Quality Engineer, you will oversee and ensure the compliance of software development processes, including software releases. You will be key in continuously improving existing and new processes, introducing efficiencies and optimizing workflows. Furthermore, you will own risk management processes related to our products, ensuring their continued safety and performance. You will be the go-to person for all things Quality Engineering, providing training and leadership to other roles within Nicolab.

Moreover, you have the following set of requirement that we want;

• You have a BSc degree in engineering or relevant engineering training;

• You have 3+ years of experience as a Quality Engineer in the MedTech industry or other strictly regulated industry;

• You have knowledge and experience with ISO 13485, ISO 14971, ISO 62304 and preferably MDR;

• You have a broad interest in all aspects of software quality, performance and safety;

• You take ownership and responsibility for quality engineering aspects within team;

• You can professionally communicate in English, and any additional languages are a plus.

What You’ll Do (Tasks & Responsibilities)

Maintain Quality of the product and product related QMS processes by; 

• Risk management products

• QMS process Software development leadership

• QMS process Product release leadership

• Training of Engineering staff on QMS processes

• Error Monitoring and escalation, & Hotfix management

• Project manager Engineering NCs and CAPAs

• Release testing (development, update, automation & execution)

• Non-medical device quality process

• Support of (medical device) product development including testing, requirements  management, risk management, documentation (architecture, technical file) for regulatory submissions and maintenance

• QMS audit support (internal & external)

• Workflow development, documentation and automation in Jira

• QMS software validation