.At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love.We are searching for the best talent for STAFF QUALITY ENGINEER to be in Juarez.Purpose:The Quality Engineer Staff plans or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously. The Engineer Staff is an emergent authority in a specific technical field, exercising considerable freedom in determining the technical objectives of assignments. The role is expected to result in the development of new or improved methods to reduce risks, equipment, materials, processes, products, and technical methods. The Engineer Staff acts as a mentor for lower hierarchy personnel and provides advice to upper management about technical matters.You will be responsible for:Business Improvement:Revision/analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and other improvement tools and programs.Performs benchmarking to develop more effective methods to improve quality.Establishes the metrics that are the quality indicators.Provides support to the development of quality engineering and compliance with adequate abilities for the introduction of new products and management of the product life cycle.Revises and approves engineering change orders (ECOs).Establishes the categories of quality costs and bases of quality cost.Compliance / Regulatory:Revises/analyzes if the current products and processes comply with regulations, such as QSRs, ISO 13485, etc., and provides support during internal and external audits.Participates in preparation activities for interactions with regulatory agencies (FDA, JJRC, BSI, etc.).Responds to internal or external audit observations related to quality engineering.Maintains the required documentation of quality assurance activities and/or quality systems.Performs periodical audits to evaluate GMPs, production controls, and lot segregation.Finances:Controls and maintains the central budget of the department/cost.New Products / Process Introduction:Works with NPI and manufacturing, process engineering, and manufacturing engineering departments to develop, conduct, and approve product and process validation strategies.Product Quality, Control and Disposition:Directs and attends Revision meetings of NCs as a member of the MRB.Conducts investigations, documentation, revision, and approval of non-conformities (NCs), preventive and corrective actions (CAPAs), and escalations of quality problems.Analyzes/revises the effectiveness of preventive and corrective actions.Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished products
