Careers that Change Lives
Develops,modifies, applies and maintains quality standards and protocol for processingmaterials into partially finished or finished materials product. Collaborates with engineering andmanufacturing functions to ensure quality standards are in place. Devises and implements methods and proceduresfor inspecting, testing and evaluating the precision and accuracy of productsand production equipment. Designs orspecifies inspection and testing mechanisms and equipment; conducts qualityassurance tests; and performs statistical analysis to assess the cost of anddetermine the responsibility for products or materials that do not meetrequired standards and specifications. Ensuresthat corrective measures meet acceptable reliability standards and thatdocumentation is compliant with requirements. May specialize in the areas of design, incoming material, productioncontrol, product evaluation and reliability, inventory control and/or researchand development as they apply to product or process quality.
Designsor specifies inspection and testing mechanisms and equipment; conducts qualityassurance tests; and performs statistical analysis to assess the cost of and determinethe responsibility for, products or materials that do not meet requiredstandards and specifications.
Reviews and analyzes quality trends with themanufacturing team.
Considering the quality trends provides directions interms of setting work priorities for process enhancement.
Provides leadership to effective in-depth investigationsand to cross-functional, multilevel technical teams to assure causes ofnon-conformance are identified and understood, and that sound corrective/preventive actions are implemented.
Evaluates the implemented corrective and preventiveactions against trends and quality issues to assess effectiveness of it.
Leads investigation of customer complaints in alignmentwith the manufacturing engineers, and process supervisors, facilitates theimplementation process.
Analyzes data based on trends, recommends actions forprocess, equipment and system improvement.
Writes procedures, protocols and any other documentationneeded for the enhancement of systems.
Provides training and education to the manufacturingteam on tools for process, monitoring enhancement, procedures and equipment,analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISOrequirements. Drives implementation of these tools.
Analyzes problems regarding inspection procedures,reaches decisions and recommends possible solutions and improvements toimplement corrective and preventive actions.
Initiates, reports, and recommends special studies andqualification of new products or processes to evaluate quality and reliability.
Analyzes and submits recommendations for facilities,environmental areas, such as particulates, humidity, calibrations, and othermonitoring.
Drives SPC or preventive action methods.
Reviews and approves qualification / validation reports,ECO's/CA's, process changes, quality records or manufacturing documentation.
Implements quality system improvements.
Conducts and assists in regulatory inspections, such as(TV, FDA, others), as well as internal audits.
Integrates Quality Systems Regulations into New Product& Technology Development.
Performs other position duties asassigned.
Findsresolution of Quality Situations at the area of responsibility.
Reportsany complaint regarding a Medtronic product to the Supervisor.
Complies with all the requirements in theoperational procedures at the area of responsibility in order to meet therequirements of all applicable Quality System regulations (e.g.: FDA Part 820Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's).
Acknowledgeand maintain commitment with the EHS Policy.
Participatein the development of EHS improvement projects.
Participateactively in the EHS programs to achieve the objectives and targets defined forthe area.
Engineers in Projects: (if apply)
Ensurethat the EHS considerations, legal and corporate requirements and efficiencyindicators are included in new project design and project evaluation in orderto maximize the cost/benefit ratio and minimize the EHS impacts and risks.
Ensurethat EHS performance indicators are included in the selection process ofcontractors.
Evaluateand re-evaluate periodically the EHS performance of contractors andsub-contractors.
Supervisethat contractors perform their job in accordance to the EHS requirements inorder to reduce, minimize or prevent EHS impacts and risks.
Maintaincurrent knowledge of the potential EHS aspects and risks of new projects.
Educational:Applied or Natural Science, Engineering or Science of Engineering or fieldrelated to previously mentioned background.
o PrincipalLevel: 7+ Years with Diploma/ Degree or 5+ Years with Advanced Diploma/ Degree
o Timeon Engineering Internship accounts as is.
Qualityand Results Oriented
Fluency speaking and writing in English and
Desired/ Preferred Qualifications
Technical Writing and Composition
Capacityto calculate, classify, compare, coordinate, copy, edit, evaluate, interview,instruct, read, observe, organize, plan, compile, select, request and document.
Light workrequiring 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.
Work is performed in building's interior withnormal temperature, good illumination, air condition, clean environment andminimum risk