Remote Digital Health Quality Assurance Job in United States Precise Solutions

Who you are

• 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

Desirables

• Experience with AI in the context of medical devices
• Experience with cyber security in medical regulatory environments
• Systems background in medical devices

What the job involves

• 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