.Job Description SummaryThe Quality Engineer is responsible for providing support to the operative personnel for in-processinspection, as well as the manufacturing related departments. The Quality Engineer role is to evaluate andimprove the QA acceptance activities and testing to ensure that medical devices being manufactured complywith all the established requirements. He serves as a lead and support to investigations were deviationshave/ or can occur to the medical devices and require an action plan to prevent further impact on product,this with the knowledge on regulations, standards, procedures, and by having a risk-based approach whendetermining the corrections and actions required to ensure the quality and compliance of the product.**Job Description**:How about becoming a maker of possible?For more than 125 years, we've pursued our Purpose of advancing the world of health. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities - For people today, tomorrow and beyond. Become a maker of possible with us!Support for Inspection and Manufacturing processesPerforms evaluation, improvement, and implementation of test method and inspection proceduresused for acceptance activities, based on established standards, and established documents.Establishes and executes test method validations.Reviews and approves of process/ product validations.Develops Risk Analysis for Waivers/ Reworks/ Sorts/ Use as is/ etc.Customer ComplaintsCoordinates periodic meetings to evaluate customer complaints trend and action plans to reducerecurrence of failures.Provides support to respond customer complaint investigations as team member.Evaluates complaints to determine applicability to manufacturing/ supplier.Performs investigations to address failures and/or trends reported by customers.Investigations/Action PlansLeads/supports CAPA investigations to address root cause and generate action plans.Performs corrective/ preventive actions as well as effectiveness check for action plans.Investigates potentials for failure to detect risk to the product/ process.External RejectionsInvestigates and responds external rejection reports (SCARs/ QNs/ etc).Reviews external rejection reports to generate action plan to reduce/mitigate incidences.MiscellaneousParticipates as support in projects for changes (design and non-design).Develops and updates the Process Failure Mode Effect Analysis (FMEA).Evaluates and proposes changes that contribute to the department costs reduction.Participates actively in the implementation of quality programs that encourage a preventionenvironment and defects or problems detection