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Quality Assurance Engineer

Skills
API TestingAttention To DetailManual TestingMobile TestingQA EngineeringQuality AssuranceTest Cases
Role

What the job involves

The main requirements, responsibilities and hiring steps.

Requirements

  • 2+ years of experience in a medical device quality department
  • Bachelor’s degree (within science, technology, or engineering discipline preferred)
  • Direct experience with facilitating verification and validation activities within medical devices and computerized systems
  • Experience with Software as a Medical Device (SaMD), including IEC 62034
  • Proven ability to interpret technical information and collaborate effectively across multidisciplinary teams
  • Experience with US FDA 21 CFR 820 and in a quality management system with regulated medical devices
  • Above average attention to detail
  • Excellent verbal and written communication skills
  • This position is fully remote

Nice to have

  • Driven by innovation and excellence
  • Passion for product quality and regulatory compliance
  • Continuous improvement mindset

Day to day

  • Facilitating product planning phases and verification and validation processes
  • Supporting testing activities and driving process improvements
  • Ensuring adherence to quality and regulatory standards for medical devices and computerized systems
  • Providing comprehensive quality assurance support throughout the product development lifecycle
  • Assisting in maintaining the quality management system

Hiring process

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