Employer will accept Bachelors degree in Scientific, Engineering, or related technical field and 3 years of work experience in job offered or 3 years of work experience in a positionrelated occupation. Experience may be gained concurrently. Any suitable combination of education, training, or experience is acceptable. Education or experience must includebr br 1. 2 years of Quality EngineeringProcess ExcellenceLean Manufacturing experience in highly regulated industry;br 2. Experience conducting ProcessDesign Failure Mode Effects and Analysis;br 3. Experience authoring and coordinating new master process validation plans for manufacturing transfers;br 4. Experience in operations and manufacturing of Class I and II Medical Devices;br 5. Medical product knowledgebr 6. Experience with Blueprint readingliteracy including GDT;br 7. Experience with inspection methods and techniques;br 8. Knowledge of the QSR, Design Controls, and ISO quality requirements;br 9. Bioinstrumentation and human anatomy experience to define functional, performance, usability and safety requirements of medical product according to the intended use;br 10. Statistical techniques and quality engineering skills needed for establishing and verifying the acceptability of process capability and medical product characteristics;br 11. Experience leading nonconformance NC and CAPA projects in highly regulated environment with minimal supervision;br 12. Experience managing productprocess improvement projects in high regulated environment with minimal supervision; andbr 13. Experience coordinating and conducting audit of external supplier quality performance.br br Some travel 10 may be required to work on projects at various, unanticipated sites throughout the United States to various JJ and Supplier Sites. May telecommute from home.
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