Senior QA Engineer (Agile methodologies)

This is a remote position.

• Lead Quality & Compliance Initiatives – Manage and validate QMS systems, automate software testing, and drive continuous quality improvements across our organization.
  
• Excellence in Quality Operations – Plan, execute, and refine processes and initiatives related to customer feedback, complaints, nonconformities, software defects, CAPAs, KPIs, and post-market surveillance.
  
• Collaborate Across Teams – Work closely with engineering, manufacturing and operations teams to ensure quality is embedded throughout our processes.
  
• Support Cutting-Edge Development – Contribute as a QA stakeholder in medical device software and instrument development, focusing on design controls and risk management.
  
• Champion Data-Driven Quality – Leverage automation, data analytics, and process optimization to enhance our Quality Management System.
  

Requirements

• Proven experience in Quality Assurance within the Medical Device industry, preferably in a leadership roles.
  
• Deep understanding of QMS principles and a track record of successful implementation.
  
• Strong background in risk management, Agile methodologies, and medical device development and/or manufacturing.
  
• Hands-on experience with automation, data management, and continuous improvement initiatives across various domains.
  
• Exceptional problem-solving, analytical, and communication skills – especially important in our remote-first culture.
  
• A pragmatic product-focused mindset, with in-depth understanding of medical device lifecycle.
  
• Knowledgeable in international regulations and standards such as EU MDR, FDA QSR, ISO 13485, IEC 62304, IEC 62366, and ISO 14971.
  

Benefits

• Work Location: Remote
  
• 5 days working