Senior Quality Engineer - Software

Client :

Join our innovative start-up, a leader in developing next-generation medical robotics for early diagnosis and treatment across various disease states.

Job Location : Hybrid (Open to San Jose or San Carlos locations)

Responsibilities :

• Provide direct support in establishing robust product and system design requirements, specifications, and verification and validation documentation.
• Gain a deep understanding of clinical applications, workflows, and user needs.
• Develop and implement software verification and validation strategies within the R&D organization, ensuring effective execution.
• Act as a key technical resource for risk management activities concerning software, adhering to ISO 14971 and IEC 62304 standards.
• Create comprehensive test plans and detailed test cases based on product and component-level requirements.
• Collaborate closely with Human Factors Subject Matter Experts (SMEs) and R&D teams to evaluate software usability throughout the design and development processes.
• Review and authorize V&V system maintenance activities related to software, including reworks and upgrades.
• Conduct thorough root cause analyses of design issues, proposing effective corrective and preventive actions using NC and CAPA systems.
• Perform audits of Design History Files and assist in both internal and external auditing processes.
• Support Regulatory Affairs with submissions, approvals, and inquiries as needed.
• Work with the PMO to utilize project management tools for defining deliverables and establishing project timelines.
• Thriving in a fast-paced environment, work collaboratively with minimal supervision or guidance.
• Maintain compliance with Noah Medical's Quality Management System, ensuring regulatory adherence.
• Champion quality best practices by applying statistical tools and techniques throughout the organization.
• Engage in additional Quality Management System activities and responsibilities as assigned.

Requirements :

Workplace Type : Hybrid