Senior Quality Engineer NPI LCM

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: Professional All Job Posting Locations: Irving, Texas, United States of America Job Description: J&J MedTech is recruiting for a Senior Quality Engineer New Product Innovation & Lifecycle Management (NPI/LCM) to join our Aesthetics & Reconstruction (A&R) organization located in Irving, Texas . Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Senior Quality Engineer NPI LCM is responsible for supporting product quality and reliability 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 individual will support product quality throughout the product lifecycle for both new product introductions and lifecycle management. The individual reviews and assesses development activities (e.g., user needs, development / quality plans, requirements, risk management, verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements. 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.

Responsibilities: Support launch and stabilize new product launches through concept, design, development, and steady-state processes. Drives the development of product requirements, verification strategies, and validation strategies. 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 analytical problem solving for product development and manufacturing. Ensures effective quality strategies for validation, including the development and validation of appropriate test methods for product and process performance Review and approve design control, manufacturing, quality, engineering and validation / qualification documents for conformance business practices and departmental procedures. Develop inspection and sampling plans, test methods, and transfer functions for products and components Supports investigation and resolution of health authority inquiries, partnering with cross function teams (including Post Market Surveillance, Complaint Handling Unit, Clinical and Medical Affairs and Medical Safety). Participates in risk management process including Application, Design, Process FMEA’s and Risk Management plans and reports. Mentor and guide Primary Quality Engineers.