Prenosis

QA Engineer

• Execute quality assurance activities for all product development activities.
• Collaborate on software design, development, and validation strategies, ensuring alignment with Quality Management Systems compliance requirements.
• Partner with cross-functional teams, including marketing, R&D, clinical, and regulatory to deliver quality, compliant products.
• Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
• Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards.
• Engage in design and development activities for both medical and non-medical software.
• Ensure cybersecurity, data privacy, and interoperability are integrated into digital product design, reviewing software artifacts for compliance and traceability.

Software Quality Engineer