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MANUFACTURING PRODUCTION MANAGER

(Regulated Industry Experience Required!)

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage manufacturing of medical device products.

• Manufacture/assembly of finished product, including printing and application of labels.

• 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.

• Completion of all documentation related to manufacturing and release of product.

• Determines the organization structure and staffing requirements of manufacturing operations.

• Ensures that performance expectations for all manufacturing personnel are clear and that all staff are properly trained and provisioned to perform with excellence.

• Responsible for overall management, motivation, direction and development of production personnel.

• Responsible continuous Improvement activities.

• Create, draft, revise SOP’s and other critical documents as needed.

• Initiate and complete Planned Deviations, CAPA’s, and Non-Conformance documentation as required.

Qualifications:

• B.S. Degree.

• Minimum 5 years of medical device manufacturing experience.

• Experience in an ISO certified and GMP environment preferred.

• Experience with Food and Drug Administration’s Quality System Regulations (QSRs), ISO 13485 and GMP is highly desirable.