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.