MANUFACTURING PRODUCTION MANAGER
(Regulated Industry Experience Required!)
ESSENTIAL DUTIES AND RESPONSIBILITIES:
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Manage manufacturing of medical device products.
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Manufacture/assembly of finished product, including printing and application of labels.
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Assisting in the establishment of an appropriate system of “Key Performance Indicators” (KPIs) that measure the efficiency and effectiveness of company’s manufacturing operations. KPIs such as: throughput, production yield, reject/scrap rate, delivery performance, etc.
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Completion of all documentation related to manufacturing and release of product.
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Determines the organization structure and staffing requirements of manufacturing operations.
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Ensures that performance expectations for all manufacturing personnel are clear and that all staff are properly trained and provisioned to perform with excellence.
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Responsible for overall management, motivation, direction and development of production personnel.
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Responsible continuous Improvement activities.
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Create, draft, revise SOP’s and other critical documents as needed.
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Initiate and complete Planned Deviations, CAPA’s, and Non-Conformance documentation as required.
Qualifications:
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B.S. Degree.
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Minimum 5 years of medical device manufacturing experience.
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Experience in an ISO certified and GMP environment preferred.
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Experience with Food and Drug Administration’s Quality System Regulations (QSRs), ISO 13485 and GMP is highly desirable.