Staff Quality Engineer, Life Cycle Management

Company: Disability Solutions
Location: Irvine
Posted on: October 19, 2024

Job Description:

Johnson & Johnson is seeking a Staff Engineer with outstanding problem-solving and analytical skills to join our Quality Engineering Lifecycle Management team in Irvine, CA!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 https://www.jnj.com/.For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.In this role you will represent the Quality Engineering function for marketed product and the state of quality and compliance throughout the product's life cycle. You will ensure sustaining engineering projects are conducted in compliance with internal, customer, and regulatory requirements!This is a unique opportunity to contribute to a world-class organization that is committed to improving health outcomes and transforming the future of healthcare. If you are ready to make a significant impact in the field of healthcare and join a global leader in innovation, we encourage you to apply now!Key Responsibilities:

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• Design Quality team member focused on lifecycle management activities associated with Neurovascular products.
• Ensures compliance to Medical Device regulations and standards, i.e. Design Control Regulatory requirements in world-wide markets for product design and supplier changes.
• Guide lifecycle management teams on efficient and effective application of design change controls and risk management. Works to identify effect of changes on design input, design outputs, failure modes, test methods and design verification and validation activities.
• Design Quality Representative for EU MDR technical documentation changes and collaborates with the Regulatory Affairs team on the preparation of deliverables for regulatory filings.
• Supports internal and external regulatory compliance audits.
• Leads thorough investigation of quality issues and effective corrective and/or preventive action plans.
• Monitors risk management process via the Post Market Surveillance process to ensure devices continue to meet intended safety and performance and drive continuous improvement.
• Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.\r\r

Keywords: Disability Solutions, Montebello , Staff Quality Engineer, Life Cycle Management, Engineering , Irvine, California