Job Summary
Production In Charge is responsible for leading and optimizing all manufacturing operations to ensure safe, efficient, and compliant production of medical devices. This role oversees production planning, resource allocation, team leadership, process improvement, quality compliance, and operational excellence while driving productivity, cost efficiency, and continuous improvement. Working closely with Quality, Engineering, Supply Chain, and other cross-functional teams, the Production Manager ensures products are manufactured in accordance with GMP, ISO 13485, and regulatory requirements, while fostering a high-performance and safety-focused production culture.
Guide and supervise the improvement of various production management indicators, including production efficiency, production capacity, product/process qualification rate and production cost reduction.
Establish the department's work processes in accordance with quality system standards, promote the reengineering of production processes, and advance the implementation of modern production management models.
Maintain a neat, clean and hygienic production environment that meets system requirements, and implement sterilization safety management and safe production in all production departments.
Conduct capacity analysis of existing products and ensure the rational allocation of personnel.
Ensure that employees understand the relevance and importance of their job responsibilities and how they contribute to the achievement of quality objectives.
Organize production in accordance with the master production schedule, establish safety stock, and ensure the timely completion of production and delivery with qualified quality.
Implement performance evaluation, motivation and management for production management personnel and operators.
Conduct on-the-job training, including Work Instructions (WI), Device History Record (DHR), operational skills, laws and regulations, and professional knowledge, to ensure employees understand the potential negative impacts or defects that may arise from improper work.
Collaborate with the Quality and Engineering teams to evaluate product issues and propose improvement recommendations and specific implementation measures.
Perform ad hoc assignments as required.
Familiarity with MRB/MES (Material Review Board/Manufacturing Execution System) systems and production management. Strong knowledge of GMP requirements, quality system standards, and applicable laws and regulations in the medical device industry. Familiarity with clean workshop production procedures and production environment standards.
More than 8 years of production management experience in Medical Devices Manufacturing Factory
with excellent coordination and communication skills, strong planning and control capabilities, practical quality management experience, and the ability to assess and handle practical quality management system issues.
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