Quality Engineer 1 NPD

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods. They are seeking a Quality Engineer 1 NPD to execute quality assurance activities to ensure effective product quality processes throughout the lifecycle of a product, while collaborating with NPD teams and supporting validation activities. Responsibilities: Provide support in quality improvement opportunities as appropriate to new products, continuous improvement and customer satisfaction. Understand the investigation processes related to corrective and preventive action (CAPA) as well as nonconformances (NC), identification of root cause and recommend action(s). Generate nonconformance reports and assist in investigation, final disposition and corrective action. Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). Assign/review quality inspection testing and test data. Communicate activities and issues to supervisor. Reviews documents for GDP. Support audits. Help execute and develop process and product validation/verification protocols and reports, equipment qualifications and engineering change orders. Qualification: Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations Ability to effectively collaborate and connect with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes Ability to function in a team environment and deliver on team objectives Strong attention to detail A minimum of a Bachelor's degree with focus in engineering and/or scientific field is preferred. Alternatively, 2+ years of quality, manufacturing, or research and development experience in a medical device or other regulated industry. Preferred: Familiarity with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices. Developed presentation skills. Understanding of theoretical and practical fundamentals and experimental engineering techniques such as DOE, DMAIC and ANOVA. Working knowledge of SolidWorks, other CAD based programs (i.e., basic dimensioning, tolerance stack analysis). Experience with Minitab, R and other statistical software. Six Sigma or lean manufacturing experience, and/or knowledge of Process Excellence tools. Experience in Class III medical devices and/or cardiac products

Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.