Are you a Quality Engineer (QE) with experience in software and medical devices, and do you enjoy taking ownership of quality in a technical environment? Would you like to work within an international medtech organization in Amsterdam, where software quality, compliance, and continuous improvement are key priorities? In this role, you are responsible for the quality and compliance of a software medical device (Class IIb) and work closely with Engineering and Compliance.

Job Description

As a Quality Engineer (QE), you are responsible for the technical quality and compliance of software development and release processes within the organization. You work as part of the compliance team and collaborate closely with Engineering to ensure products and processes comply with MDR, ISO 13485, ISO 14971, and IEC 62304. You combine hands-on execution with process improvement and act as a subject matter expert in software quality and risk management.

Key Responsibilities

  • Maintain and continuously improve QMS processes related to software development and product releases
  • Take ownership of software risk management and quality documentation
  • Support Engineering with requirements management, testing, and validation
  • Coordinate and follow up on deviations, CAPAs, and change controls
  • Support internal and external audits
  • Train and advise Engineering colleagues on quality and compliance topics

Requirements

  • Bachelor’s or Master’s degree in Engineering or a related technical field
  • Approximately 3 years of experience as a Quality Engineer or Software Engineer within medical devices / SaMD
  • Knowledge of ISO 13485, ISO 14971, and IEC 62304 (MDR is a plus)
  • Affinity with software development and technical quality
  • Independent, proactive, and comfortable taking ownership
  • Excellent command of the English language

Company Profile

The organization is an internationally operating medtech company developing AI-driven software for medical imaging analysis. It is a small, growing organization with an entrepreneurial culture, short lines of communication, and plenty of room for initiative and responsibility.

Employment Conditions

  • Permanent position (initial 12-month contract)
  • 32–40 hours per week
  • Location: Amsterdam, with remote working possible depending on seniority
  • Salary indication: €70,000 – €90,000 gross per year
  • Equity / stock option plan
  • Flexible working hours and an international working environment

Contact

Interested in this role or have questions? Please contact Annebeth Simons via a.simons@morgangreen.nl or call +31 30 20 03 408.