Staff Quality Engineer

CrossRoads is recruiting for a Staff Quality Engineer , to be located in Memphis, TN .

DePuy Synthes , part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

CrossRoads, recently acquired by DePuy Synthes , part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

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We are looking for someone to support the New Product Development Quality group to implement engineering and quality systems, and regulatory compliance strategies and objectives. As the Staff Quality Engineer you will get hands-on experience as part of a team to implement state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations.

Key responsibilities:

• Product development team member focused on product development and life cycle management activities related to the CrossRoads business.
• Lead design and development planning activities for new and sustaining projects.
• Participate in all aspects of the creation and execution of functional/design requirements for new and sustaining projects.
• Conduct formal technical design reviews throughout the phases of the product development process.
• Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.
• Apply statistical methods and design excellence tools to design verification and validation activities.
• Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting.
• Support transfer to manufacturing activities both in product development and base businesses.
• Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.
• Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
• Provide leadership in the understanding of medical device regulations to other disciplines.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing.
• Work closely with suppliers on the qualification of new/changed parts and processes supporting product development. This person will conduct assessments of new suppliers as part of the project teams.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics , and compliance at all times.
• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
• Additional duties as assigned.