Staff Quality Engineer (Software)

Client :

Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.

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

Responsibilites :

• Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
• Understand clinical applications, workflow and user needs
• Develop software-related verification and validation strategies for the R&D organization and ensure the execution of the strategies.
• Serves as a technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304.
• Develop test plans, and test cases based upon the product and component level requirements.
• Partner with Human Factors SMEs and R&D to assess the usability of the software throughout design and development
• Review and approve V&V system maintenance such as reworks and modification and tracking related to software upgrades.
• Perform root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
• Perform audits of Design History Files and support both internal and external audits.
• Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
• Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
• Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance.
• Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
• As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.
• Other QMS activities not specified here and as assigned.

Requirements :

Workplace Type : Hybrid