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 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. Reviews and analyzes quality trends with the manufacturing team. Considering the quality trends provides directions in terms of setting work priorities for process enhancement. Provides leadership to effective in-depth investigations and to cross-functional, multilevel technical teams to assure causes of non-conformance are identified and understood, and that sound corrective/ preventive actions are implemented. Evaluates the implemented corrective and preventive actions against trends and quality issues to assess effectiveness of it. Leads investigation of customer complaints in alignment with the manufacturing engineers, and process supervisors, facilitates the implementation process. Analyzes data based on trends, recommends actions for process, equipment and system improvement. Writes procedures, protocols and any other documentation needed for the enhancement of systems. Provides training and education to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical trouble-shooting, FMEA, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools. Analyzes problems regarding inspection procedures, reaches decisions and recommends possible solutions and improvements to implement corrective and preventive actions. Initiates, reports, and recommends special studies and qualification of new products or processes to evaluate quality and reliability. Analyzes and submits recommendations for facilities, environmental areas, such as particulates, humidity, calibrations, and other monitoring. 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 (TÜV, FDA, others), as well as internal audits. Integrates Quality Systems Regulations into New Product & Technology Development. 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 Molding Knowledge 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
