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Quality Engineer

Permanent employee, Full or part-time · Amsterdam, Australia (VIC), Spain (Madrid), Germany, Belgium, Spain (Barcelona), Australia (NSW), Italy, Remote
Your mission
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.

What You Will Do
Core Quality Engineer tasks, goals and responsibilities

  1. Risk management products
  2. QMS process Software development leadership
  3. QMS process Product release leadership
  4. Training of Engineering staff on QMS processes
  5. Error Monitoring and escalation, & Hotfix management
  6. Project manager Engineering NCs and CAPAs
  7. Release testing (development, update, automation & execution)
  8. Non-medical device quality process
  9. Support of (medical device) product development including testing, requirements management, risk management, documentation (architecture, technical file) for regulatory submissions and maintenance
  10. QMS audit support (internal & external)
  11. Workflow development, documentation and automation in Jira
  12. QMS software validation
Your profile
What we're looking for
  • You have a passion for software quality and are driven to communicate and improve implementation of compliant practices related to our product and the entire company.
  • You have experience working in an ISO 13485 compliant management system and have knowledge of ISO 14971 and ISO 62304 and preferably MDR.
  • You are always looking for innovative approaches to establish and maintain compliance to regulations and requirements and keep our quality management system efficient and lean to facilitate growth and maintain flexibility.
  • You embrace the start-up mindset. 
  • You thrive in a young and international environment. 
  • You adapt to changing company structure and goals. 
  • You support commercial needs. 
  • You enjoy the challenge to achieve the best results with limited resources.

What you'll bring
  • BSc degree or higher in engineering or related field.
  • 3+ years of experience in software as a Medical device as Quality engineer or Software developer.
  • 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 Nicolab and communicate proactively throughout the organization.
  • Communication skills, written and oral, in English, additional languages are a plus.
Why us?
We Offer You
  • Chance to make a real difference in patients' lives
  • Work in a stimulating environment with a motivated team
  • Flexible Employment Agreement: Part time / Fulltime / Remote (EOR Contract*)
  • Flexible working hours
  • Flexible paid time off*
  • Remote work policy
  • Laptop + home office/IT equipment*
  • Commuting to work - costs reimbursement
  • Pension plan scheme*
  • 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 22,00 courses on LinkedIn Learning Solutions and much more

    *All benefits and perks are subject to certain eligibility requirements

Application Process
  1. Interview with Recruiter/HR
  2. Interview with Future Manager (hiring manager)
  3. Interview with Peers (no managers present) 
  4. Interview with Executive
       - Prior employment verification check
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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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We are looking forward to hearing from you!
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