**Responsibilities:** + Responsible for supporting the development of corrective/preventive actions (CAPA) corresponding to the assigned manufacturing area. + Coordinate/lead root cause investigation tasks with investigation team. + Coordinate non-conforming product hold, as well as potentially affected product. + Coordinate inspection and necessary tasks to duplicate failure mode, as well as ES necessary to quality assurance. + Follow up on all CAPA tasks are completed in a timely and proper manner. + Participate in conference calls, presentations and meetings with plant teams and upper management. + This position will be required to support and respond to internal audit observations and corrective actions.Timely and proper response to these requirements will be tied directly to annual performance reviews. + Develop Monitor and Trending Investigation Reports for market complaint. + Create CCNs and CCRs. + Responsible of developing and participate in projects and investigations with its principal intention of improving product’s quality in general, although their participation can be required in savings projects. + Be able to develop and implement quality plans, including tracking, analyzing, reporting, and problem solving. + Responsible of risk analysis assignation for CAPA’s and NC’s. + Assist Regulatory Affairs and Engineering personnel in new product/process design, specifications and changes to assure effective control procedures are established. Participate actively in product and process start-ups. + Investigate product’s quality problems, determine root cause, gather and analyze data and implement corrective actions to reduce or eliminate cause. + Data analysis of market complaints intended to identify quality problems. + Responsible of keeping “complaints goals” quality goals within target. **Requirements:** + Bachelor’s Degree in Engineering. + Bilingual English / Spanish. + Excellent interpersonal, verbal and written communication skills. + Good technical and analytical skills. + Statistical techniques knowledge (Six-Sigma methodology preferred) + Knowledge on computing tools + Problem solving and root cause analysis + Process and Test Method Validations. + Experience with Medical Devices. **Responsibilities:** + Responsible for supporting the development of corrective/preventive actions (CAPA) corresponding to the assigned manufacturing area. + Coordinate/lead root cause investigation tasks with investigation team. + Coordinate non-conforming product hold, as well as potentially affected product. + Coordinate inspection and necessary tasks to duplicate failure mode, as well as ES necessary to quality assurance. + Follow up on all CAPA tasks are completed in a timely and proper manner. + Participate in conference calls, presentations and meetings with plant teams and upper management. + This position will be required to support and respond to internal audit observations and corrective actions.Timely and proper response to these requirements will be tied directly to annual performance reviews. + Develop Monitor and Trending Investigation Reports for market complaint. + Create CCNs and CCRs. + Responsible of developing and participate in projects and investigations with its principal intention of improving product’s quality in general, although their participation can be required in savings projects. + Be able to develop and implement quality plans, including tracking, analyzing, reporting, and problem solving. + Responsible of risk analysis assignation for CAPA’s and NC’s. + Assist Regulatory Affairs and Engineering personnel in new product/process design, specifications and changes to assure effective control procedures are established. Participate actively in product and process start-ups. + Investigate product’s quality problems, determine root cause, gather and analyze data and implement corrective actions to reduce or eliminate cause. + Data analysis of market complaints intended to identify quality problems. + Responsible of keeping “complaints goals” quality goals within target. **Requirements:** + Bachelor’s Degree in Engineering. + Bilingual English / Spanish. + Excellent interpersonal, verbal and written communication skills. + Good technical and analytical skills. + Statistical techniques knowledge (Six-Sigma methodology preferred) + Knowledge on computing tools + Problem solving and root cause analysis + Process and Test Method Validations. + Experience with Medical Devices.