Quality Assurance Engineer
Skills
API TestingAttention To DetailManual TestingMobile TestingQA EngineeringQuality AssuranceTest Cases
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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