.Job Description - SENIOR QUALITY ENGINEER (TERCER TURNO) (DOS POSICIONES) (1 DE 2) (2406211762W)DescriptionAt Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.We are searching for the best talent for Senior Quality Engineer to be in Ciudad Juarez, Mexico.Purpose:Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, and quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA, and other worldwide regulatory agencies.You will be responsible for:Working in Quality Engineering and with other functional groups in support of new product/process development, quality operations, or quality assurance.Utilizing Quality Engineering tools/processes to develop and implement practices for effective and efficient product/process lifecycle management.Leading efforts with quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction.Developing and establishing effective quality control and risk management plans.Writing, reviewing, and approving process and product validation protocols and reports.Using statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).Ensuring that development activities follow design control requirements and product testing meets applicable standards.Supporting vendor audits and Supplier Quality as a Quality representative.Initiating and investigating Corrective and Preventative Actions (CAPA).Assisting in complaint analysis and Regulatory Affairs submissions.Participating in design reviews and pre-validation assessments.Supervising and providing guidance to Inspectors and Technicians in Quality activities.Communicating business-related issues or opportunities to management.Ensuring compliance with all health, safety, and environmental practices.Performing other duties as assigned
