The Netherlands, Australia, Belgium, Germany, Italy, Remote, Spain
Full or part-time
Your mission Company Description
At Nicolab we connect the physicians and streamline their emergency care workflows, providing physicians with AI-analyzed scans and centralized patient information.
We currently are..
Operational in 10+ countries across 4 continents
Established presence in Europe and Australia
Quickly expanding to China, Middle East and the rest of Europe and Australia
30+ employees across the world, with an office in Amsterdam and Australia
Role Description
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.
Key Responsibilities
Maintain Quality of the product and product related QMS processes
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)
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
Your profile Qualifications
Strong expertise experience with ISO 13485, ISO 14971, ISO 62304 and preferably MDR;
Proficient in Quality Engineering and Quality Control methodologies
Experience with Quality Assurance processes and procedures
Strong understanding of Product Quality and Quality Management principles
Familiarity with quality frameworks, tools, and regulatory compliance standards
Exceptional analytical and problem-solving skills
Strong communication in English and collaboration abilities
Bachelor's degree in engineering, quality management, or a related field
3+Years experience in healthcare technologies or medical software development is a plus
Why us?
Chance to make a real difference in patients' lives
Work in a stimulating environment with a motivated team
Flexible paid time off*
Laptop + home office/IT equipment*
Commuting to work/office* - costs reimbursement
Employee Stock Option Plan (ESOP)*
Corporate programs including Employee Referral Program with rewards
Learning & Development opportunities including in-house training and coaching, professional certifications, and over 22,000 courses on LinkedIn Learning Solutions and much more
*All benefits and perks are subject to certain eligibility requirements based on location
Application Process
Interview with Recruiter/HR
Interview with Future Manager (hiring manager)
Technical assessment with Peers (no managers present)
Prior employment verification check (reference/background check)
Interview with Executive
About us
Nicolab was founded in 2015 following the acclaimed MR CLEAN trial, the first Randomised Clinical Trial proving the benefit of Endovascular Treatment. The trial led to a global paradigm shift in acute stroke care and triaging, resulting in the hospital Hub and Spoke model.
Leading MR CLEAN researchers and our co-founders, Dr. Merel Boers and Dr. Renan Sales Barros, recognized the need for an AI solution to revolutionize stroke care. With exclusive access to the heterogeneous MR CLEAN dataset, Nicolab developed StrokeViewer. StrokeViewer provides the most accurate AI algorithms to diagnose stroke patients worldwide.
Our background is steeped in leading clinical research, which is why we continue to invest and contribute significantly to research, ensuring that Nicolab remains at the forefront of driving innovative change and improving outcomes for stroke patients.
While Nicolab continues to run its operations with Headquarters in Amsterdam, The Netherlands, we are proudly an Australian-based publicly unlisted company with an expanding global presence.
Visit our website: Nicolab.com
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