.Job Description - SENIOR QUALITY ENGINEER (SEGUNDO TURNO)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.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, and other worldwide regulatory agencies. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout the lifecycle of the product.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 in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.Developing and establishing effective quality control and supporting associated risk management plans.Writing, reviewing, and/or approving process and product validation protocols and reports, equipment qualifications, and engineering change orders.Using statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).Determining sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.Ensuring that development activities follow design control requirements, product is tested per applicable standards, and product is properly transferred to manufacturing.Providing all planning necessary to ensure effective product acceptance, including part qualifications, specification development, and sampling plans.Supporting vendor audits as technical lead as needed and supporting Supplier Quality as Quality representative as appropriate.Initiating and investigating Corrective and Preventative Actions (CAPA) as appropriate.Assisting in complaint analysis as appropriate
