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Five or more years of quality system management ? Bachelor?s degree in Engineering or related field? Minimum 4 years of experience with FDA regulated industry ? Experience in leader teams, excellent communication skills.? Strong analytical skills and attention to detail.? Excellent interpersonal andwritten communication skills.? Demonstrated ability to effectively organize, prioritize and accomplish multiple tasks, make decisions and solve problems independently.? A thorough knowledge of 21 CFR 820 and ISO 13485.