Quantum Surgical

Risk

• Develop and maintain product risk management files
• Perform risk management activities with cross-functional teams to ensure product safety and compliance
• Understand clinical performance, product functionality, and the operating-room environment
• Participate in and organize risk management activities throughout the product lifecycle, through post-market surveillance
• Advise and guide engineering teams involved in risk management
• Conduct product and process risk analyses, particularly FMEAs
• Identify residual risks and perform the associated benefit-risk analysis
• Create and update risk management documentation
• Collaborate with subject-matter experts responsible for medical device usability
• Ensure compliance with quality procedures, regulatory requirements, and applicable industry standards
• Participate in the preparation of CE-marking and 510(k) regulatory dossiers
• Participate in nonconformity management and change control
• Participate in complaint handling and assess associated risks
• Participate in the development of corrective and preventive action plans
• Collaborate with Systems, Software, Robotics, Mechanical Engineering, Integration, Verification and Validation (IVV), Quality, Regulatory Affairs, Clinical, and Project Management teams

Explore Risk Engineer – Medical Device at Quantum Surgical. Review requirements and application details.

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Risk Engineer – Medical Device