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Digital Health Quality Assurance
Skills
Software TestingDesign ControlDigital HealthManual TestingProduct QualityQuality AssuranceSpelling
What the job involves
The main requirements, responsibilities and hiring steps.
Requirements
- Bachelor’s degree preferably in sciences, engineering, or other technical/scientific area
- 5+ years of industry experience or 3+ years with a Master’s degree in Quality Assurance, Development, or healthcare-related field
- Experience in coordination and planning of complex activities
- Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, 21 CFR 820.30, and EU MDR
- Experience with the creation and maintenance of QMS documents for medical devices development
- Practical experience in design control and risk management
- Effective use of oral and written communication skills to clearly communicate the quality position and necessary actions to resolve issues
- Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
- Experience in a highly regulated environment
Nice to have
- Experience with AI in the context of medical devices
- Experience with cyber security in medical regulatory environments
- Systems background in medical devices
Day to day
- Represent QA on cross-functional SaMD and Digital Health Software development teams and execute Quality System requirements to ensure compliance with worldwide Medical Device Regulations
- Author, review, and approve project documentation associated with SDLC and design control requirements
- Create and maintain QMS documents for the development of SaMD and Digital Health Software Products in compliance with global regulations
- Support the creation of regulatory submission documentation
- Monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements