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 toolsProblem solving and root cause analysisProcess and Test Method Validations.Experience with Medical Devices.