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Quality engineers monitor and audit the quality of all manufactured goods in a variety of industries, including the automobile, textile, clothing, food and electronics industries. They work to not only find defects, but also to find the cause of the defect and develop a solution. Education Required 1. A BS degree in Engineering, Science, or other related field is required. In certain cases, experience may replace formal education. 2. Continuing education, including training in Quality, Auditing, Continual Improvement, ISO 9001, ISO 13485, and/or CAPA is strongly desired. 3. A certification from the American Society for Quality, or equivalent, is strongly desired (e.g., CQE, CQA, etc.)
Relocation costs may be covered.
1. Understand and be able to work with ISO 9001:2008, ISO 13485:2003, and 21 CFR Part 820, as well as EPA and OSHA Regulations, hazardous chemicals, and safety management; 2. Assist Quality Manager in establishing, implementing, and maintaining the quality management system; 3. Responsible for Quality System Maintenance on the floor of a Custom Injection Molding and Medical Device manufacturing plant; 4. Interpret technical drawings including characteristics such as views, title blocks, dimensioning, tolerancing, etc. Interpret specification requirements in relation to product and process characteristics; 5. Implement acceptance sampling procedures, understand and implement sampling standards and plans; 6. Understand and use measuring and monitoring tools for the release of product, perform Gauge R & R studies, etc.; 7. Identify and apply various evaluations and tests to qualify and validate the design of new products and processes to ensure their fitness for use; 8. Root cause analysis and implementation of corrective action for product and process related concerns; 9. Material Control, including material identification, status, and traceability, material segregation, and classification of defective material, serve on Material Review Board, take responsibility and oversight of nonconforming product processes and dispositions; 10. Responsible for continual improvement activities to enhance the quality system, such as 5-S, Kaizen lean methods, etc., understand quality control tools, e.g., select, construct, apply, and interpret tools such as 1) flowcharts, 2) Pareto charts, 3) cause and effect diagrams, 4) control charts, 5) check sheets, 6) scatter diagrams, and 7) histograms 11. Develop a complete training program and be able to demonstrate the effectiveness of the system; 12. Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data; 13. Train and support the Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system, report deficiencies to Quality Manager and be able to problem solve to develop creative solutions to problems; 14. Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions; 15. Analyze failure, corrective and preventive action to respond to customer complaints; 16. Assist in creating and maintaining company quality documentation, such as, procedures, work instructions, specifications, etc.; 17. Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions 18. Continuously improving QA receiving inspection process and procedures 19. Ensure timely resolution of supplier failure, corrective actions, and preventive actions 20. Manage suppliers??? performance and possibly conduct audits 21. Preparation of QA reports Other Required Skills 1. Must have excellent communication skills, verbal, non-verbal, and written. 2. Must have a high degree of knowledge with Microsoft Outlook, Word, PowerPoint, and Excel; working knowledge in Projects is desired. 3. Must be able to read simple drawings and the information contained within them. Working knowledge of a CAD program is desired. 4. Must have strong mathematical skills and be able to use precision measuring tools with a high degree of accuracy. 5. Must have experience in performing quality audits, internal, second party, and third party. 6. Must be highly skilled in writing reports and communicating data.
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