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The Quality Engineering Manager supports the OTTAVA TM Surgical Robotics Platform, responsible for leading product quality and reliability while ensuring the implementation of ground-breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Working closely with multi-functional teams, this people leader will act as a domain authority for product quality throughout the development lifecycle. The Quality Engineering Manager will lead a team of Development Quality Engineers focusing on Instrument & Accessories. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits.

Key Responsibilities:

• The Quality Engineering Manager will lead a small team of direct reports potentially including engineers, technicians, and contractors.
• Drives the development of product risk management, design requirements, verification strategies, and validation strategies.
• Launch and stabilize new product launches through concept, design, development, and steady-state processes.
• Ensures new product development compliance to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and any other applicable standards
• Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Proactively engage partners to drive consensus and resolve issues in a timely fashion.
• Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
• Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures.
• Provide support and expertise in developing and executing a reliability strategy during new product development.
• Conducts projects and assignments with technical responsibility.