Position Description Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Position Responsibilities Reviews potential or material quality issues in order to coordinate corrective/preventive actions with suppliers. Supports transfer for incoming inspection responsibilities. Supports training and certification of incoming inspectors Develops qualification plans and reports to assure components, materials and supplier meet specified requirements. Maintains and updates components information on manufacturing execution systems or information systems. Applies problem-solving skills to the corrective action process and eliminate problem root cause through long-term preventive action. Drives and implements corrective / preventive actions and prepares materials corrective and preventive action reports Supports the evaluation and selection of global best-in-class suppliers through the application of quality tools and measurements. Drives supplier development program on an effort to reduce receiving inspection and correct and prevent component related rejection in manufacturing and field. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited Develops and maintains inspection procedures for components and materials to support manufacturing. Supports incoming inspection activities. Resolves material quality issues, specifications and inspection procedures questions at the incoming inspection area. Evaluates, selects, validates and qualifies equipment /tools / technologies for accurate inspection, including fulfilling financial requirements for capital equipment acquisitions. Performs other position duties as assigned Quality Responsibilities Reports any observed or informed process and/or product non-conformities to the Supervisor. Finds resolution of Quality Situations at the area of responsibility. Reports any complaint regarding a Medtronic product to the Supervisor. Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Acknowledge and maintain commitment with the EHS Policy. Participate in the development of EHS improvement projects. Participate actively in the EHS programs to achieve the objectives and targets defined for the area. Engineers in Projects: (if apply) Ensure that the EHS considerations, legal and corporate requirements and efficiency indicators are included in new project design and project evaluation in order to maximize the cost/benefit ratio and minimize the EHS impacts and risks. Ensure that EHS performance indicators are included in the selection process of contractors. Evaluate and re-evaluate periodically the EHS performance of contractors and sub-contractors. Supervise that contractors perform their job in accordance to the EHS requirements in order to reduce, minimize or prevent EHS impacts and risks. Maintain current knowledge of the potential EHS aspects and risks of new projects. Minimum Education Bachelor Degree Basic Qualifications Background Educational: Applied or Natural Science, Engineering or Science of Engineering or field related to previously mentioned background. Experience: o Senior Level: 5 Years with Diploma/ Degree or 3 Years with Advanced Diploma/ Degree o Time on Engineering Internship accounts as is. Exposure to quality engineering and manufacturing environment Skills Analytical Thinking Problem Solving Interpersonal Relations Quality and Results Oriented Computer Literate Fluency speaking and writing in English and Spanish Desired/Preferred Qualifications Background Experience in medical device, pharmaceutical, or electronic industry ASQC Certification Statistical Techniques Test Method Validation Skills Teamwork Communications Continues Improvement Project Management Root Cause Analysis Technical Writing and Composition Working Conditions Mental Components: Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document. Physical Components: Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment. Environmental Work is performed in building's interior with normal temperature, good illumination, air condition, clean environment and minimum risk SDL2017
