Careers that Change Lives Position Description Assists with qualification process; troubleshootany equipment malfunction; set-up and fine-tune equipment. Adjusts equipment setting in order to buildsamples as per Experiment's Design, or qualification/validation plans. Conducts any testing and take measurements asrequired in the plan. Properly documentsactivities and record test results. Provides direct support to the production line and operators. Monitors process and equipment performance,and takes preventive action. Partnerswith Engineers, Quality, and Production personnel to quickly contain andprevent any quality related issues. Evaluates potential nonconforming product. Under the guidance of ManufacturingEngineers, participates on equipment Buy-Off activities, performs initialequipment installation and qualification, prepares list of spare parts, anddefines PM procedures and frequency. Trains line technicians on equipment functionality, and PMprocedures. Physically arranges and movesworkstations and equipments as per the latest Layout plan. Assists engineers in implementing ECOs. Prepares technical reports as required. Position Responsibilities Conductsinvestigation of quality issues and documents as per established policy.Assures product containment within available systems. Gathersinformation for the quality engineers, in order to address product issues Performsanalysis using lean sigma tools as part of quality issue investigations. Assistsin the development of training and working standards including, but not limitedto, visuals, pictorials, or other mechanisms. AssistsQuality Engineering in the development / implementation of procedures, workinstructions or forms, as required. Performsquality audits to the manufacturing line and rearrange schedule based ontrending. Providesdirect support to the production line and operators related to quality issues. Providesadequate tools and equipment to ease device inspection. Presentdata or explains situations affecting quality to manufacturing personnel whenrequired. Preparesmaterial and data to be presented in quality review meetings. Worksand implement special projects when required including but not limited to CAPA,Continuous improvement projects, etc. Evaluatesproduct/material discrepancies (PRB/MRB), and implement corrective actions on atimely manner Performsqualifications / validations for product/processes and equipment, as required. Assessadequacy of process inspection points based on process FMEAs. Supportsproduct transfers and new implementations. Assistsin the investigations of quality issues and non-conforming situations asrequired. Preparesand presents trend data pertaining to the calibration area during monthlyQuality Review meetings. Assistsin gathering of information during FDA inspections, Notified Body Audits,Corporate Audits, etc. Performother position duties as assigned. Supportmanufacturing course/certification in the applicable LMS System. Supporton-the-job training plan to assure personnel compliance. Workswith document changes in the applicable system (ex. change of manufacturing /quality document changes in Agile) Quality Responsibilities Reportsany observed or informed process and/or product non-conformities to theSupervisor. Findsresolution of Quality Situations at the area of responsibility. Reportsany complaint regarding a Medtronic product to the Supervisor. Complieswith all the requirements in the operational procedures at the area ofresponsibility in order to meet the requirements of all applicable QualitySystem Regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Acknowledgeand maintain commitment with the EHS Policy Participatein the development of EHS improvement projects Participate actively in the EHS programs to achievethe objectives and targets defined for the area Minimum Education Associate Degree or 60 undergraduate approvedcredits as equivalent Basic Qualifications Background Educational:Electronics, Engineering Technology, Industrial Technology or related field Experience: o IntermediateLevel: 3 Years with Associates or 0Years with Bachelors Ableto read schematics and have an understanding of analog and digital circuits,Operate test equipment and Soldering experience Skills AnalyticalThinking ProblemSolving InterpersonalRelations Qualityand Results Oriented ComputerLiterate Basic oral and written communication skills in Spanishand English Desired/ Preferred Qualifications Background Experiencein medical device, pharmaceutical, or electronic industry Skills Teamwork Communications ContinuesImprovement ProjectManagement Good Mechanical Skills, use of small hand tools. Working Conditions Mental Components: Capacityto calculate, classify, compare, coordinate, copy, edit, evaluate, interview,instruct, read, observe, organize, plan, compile, select, request and document. Physical Components: Lightwork requiring physical effort, in addition, requires communication skills,capability to move from one place to another, visual discrimination andtolerance to the use of personal protection equipment. Environmental Work is performed in building's interior with normaltemperature, good illumination, air condition, clean environment and minimumrisk SDL2017
