Review results of area audits to ensure that corrective and preventive actions are adequate, As applicable, Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others, Product Quality, Control & Disposition and Performance Standards, Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing, Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality, Production/Process Controls including Control Plans, Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed, Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc, Develop, interpret and implement standard and non-standard sampling plans, Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Six Sigma Green Belt offering three years of experience in quality engineering, lean manufacturing and product/process design. In lieu of a degree, 13 years of related experience is required, A seasoned (5+ years) professional with experience in defense and space applications and background in Quality/mission assurance, Proven problem solving skills, including: ability to interpret business needs, identify issues, define actions, and implement solutions, Understanding and practical application of Root-Cause/Corrective Action (RCCA) principles, Ability to independently and effectively interface with others in a self-directed environment, Excellent written and spoken communication skills, Previous experience with technical writing and training, Establish and manage appropriate quality tracking mechanisms with the operations area to drive improvement based on real time data, Utilize above mentioned quality data to prioritize issues to be addressed and lead/collaboratively work with all functions to establish true root cause and irreversible corrective actions, Make appropriate cross functional decisions using quality analysis tools and critical thinking including cost/impact analysis and customer impact, Develop and maintain appropriate controlled area for assembly non-conforming material, Daily production line support on making daily decisions related to product quality; serving as the voice of the customer, Bachelor's degree from an ABET accredited program, Exposure in statistics and engineering terminology and total quality management, Ability to communicate cross functionally, internally/externally as well as to all levels of the organization, Specific education, training and proficiency in quality disciplines including ISO, TS16949, PPAP, FMEA, DOE, and SPC, Primary responsibilities include assisting in a supporting role on new product development, sustaining and supply chain quality projects. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, Ability to work in our environment - while performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and high, precarious places. MBA desired, not required, Outstanding problem solving and conflict resolution skills. Mean shifts and SPC data, Ensure that an investigation takes place on all process failures, such as corrective actions, PDCA, Teardown PDCA, RMA, product audit Issues, Perform system audits of part production programs and part reviews to ensure acceptable quality levels are maintained and properly monitored, Make decisions and advise on an on-going basis to insure customer and management directives are met, Coordinate and track progress for interdepartmental studies, Take additional training to maintain pace with new technology. Mass Production inspection instruction preparation and update. Medical Device Quality Engineer Resume. Utilizes statistical analysis to ensure process is capable, Trains less experienced Engineers on department processes or systems, Implements the activities defined by the Quality Manager to support the plant operation and quality assurance department. Displayed here are job ads that match your query. It’s actually very simple. The employee must occasionally lift and/or move up to 30 pounds. Physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. A Validation Engineer usually performs tasks like testing the systems that are used to manufacture goods. Assists product and process engineers in the development of new or improved processes that minimize scrap and rework and meet technical guidelines and business requirements, Completes Material Review Board (MRB) disposition on production non-conformances to ensure compliance with internal and customer requirements utilizing knowledge, continuous improvement tools, engineering resources, and assistance of more experienced engineers, Supports production employees, inspection staff, and cell staff by evaluating, interpreting, and providing feedback regarding customer and company requirements and specifications, Support and follow all rules/guidelines/standards set by EHS, Quality, and Continuous Improvement functions as set by leader and position, Performs Quality Assurance for Victoria by performing product test procedures, validating product specifications, performing audits, and leading product reliability improvements via Caterpillar’s Continuous Product Improvement programs, Develops plans and tools to support quality systems and related processes. ITAR defines a U.S. person as a U.S. Citizen, U.S. An advanced degree is degree is preferred, American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred, Ability to develop and implement Quality standards is preferred, Knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices is preferred, Knowledge of and/or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is required, Proven experience of project management skills to fulfill supply chain and sustain product requirements is required, Exposure to Six Sigma tools and methodologies are preferred, Lean manufacturing experience is preferred, Understanding of business and financial metrics is desired, Basic understanding of theoretical and practical fundamentals and experimental engineering techniques are preferred, Lead a team of Quality Technicians and Inspectors, Lead, facilitate and execute quality operational activities in direct support of manufacturing production and quality improvement projects, Drive customer critical-to-quality requirements down to critical feature control plans supporting expected process capabilities, Develop process failure mode and effects analysis (FMEA) so that high risk items are proactively identified and mitigated in the product and process development stages, Monitor processes by developing, collecting, analyzing, and reporting quality statistics and metrics to qualify process capability, sustain process control, support problem resolution and promote continuous improvement, Participate in activities around sourced component quality including production part approval (PPAP), proactive quality problem resolution, and projects to improve supplier quality, Participate in process reviews and assist manufacturing engineers in identifying process improvements, definition of key product characteristics, necessary process controls and product validation tests, Lead resolution of quality related issues on the manufacturing floor including the disposition of non-conforming material as required, Serve as a quality resource for product development and process improvement teams and ensure the presence and integrity of quality criteria in both product and process documentation including quality criteria change control, Develop core skills within team members to enhance the corporations ability to drive improvement, Bachelor’s degree in engineering is required. Root Cause Corrective Analysis (RCCA), 5 Why, Fishbone, etc.) Positive learn English, Provide technical support to machining and assembly operations, Perform Product/process reviews and support AS 9100 audits, Track and report on all Metrics including first pass yield (or PPMD), scrap performance, capability studies, etc, Provide support of SAP, Quality computer systems and Visiprise (MES), Perform CAR responses and follow up for robust CAPA, Provide support to the Operations organization relative to the collection and analysis of Quality data including scrap to support to the Plant's performance, Develop and analyze statistical data and product / process performance to recommend and implement improvements in targeted areas, Provide expertise in Quality process improvement tools and methods to targeted functions of the organization to support them in their continuous improvement activities, Provide support in the way of development and evaluation of process capability, process control plans, analysis of out-of-control conditions and process audits with the objective of improving process performance and capability, Develop tests using new or existing automation infrastructure, Evaluate product features and participate in product test planning, Evaluate product quality needs and develop test plans, Deliver clear status for testing areas in a timely manner, Develop regression test cases to prevent discovered issues from reoccurring, Maintain a thorough understanding of product functionality, Effective oral and documented communication with Customers, Company personnel and suppliers, Thorough knowledge and participation in Advanced Product Quality Planning, Ensure PPAP submitted and approved on each part and maintained in an organized fashion, Prepare Corrective Action Reports for customer and internal concerns, Detailed knowledge and preparation to achieve approved Process Sign Off, both customer and supplier, Keep as confidential all information pertaining to customer prototype requirements, Ensure supplier corrective actions are documented, implemented, effective, and timely closure, Take part in quality training functions as required, A minimum of three years experience working in a Quality environment utilizing knowledge of prototype product development of products in accordance with customer requirements. 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