Quality Engineering Manager, New Product Development - Cincinnati Ohio

Company: Disability Solutions
Location: Cincinnati, Ohio
Posted On: 05/04/2024

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at 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. More...

      

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