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Position Summary: Strategically lead the Setup area to ensure efficient order preparation, continuous flow into production, and compliance with quality standards in medical device manufacturing. Key Highlights: 1. Strategic leadership in medical device manufacturing 2. Driving continuous improvement and operational excellence 3. Developing technical competencies and operational discipline **Job Description** **General Description:** Strategically lead the Setup area and collaborate cross-functionally to ensure efficient, accurate, and timely work order preparation, guaranteeing continuous flow into production, reduction of downtime, optimal material control, and compliance with quality standards in a medical device manufacturing environment while strengthening the area’s operational discipline. The role must exercise leadership aligned with the organization’s culture as an employer (GPTW), promoting an environment of trust, collaboration, and high performance. Additionally, the role must drive continuous improvement under the MKOS Model principles, focusing on operational excellence, standardization, and sustainable process improvement. **Responsibilities:** ***Operational Excellence*** * Ensure timely release of work orders without impacting the production schedule. * Reduce setup time and material picking errors. * Optimize layout, rack flow, and visual controls. * Implement process improvements in scanning, verification, and location management. * Establish preventive controls to avoid inventory discrepancies and DHR errors. ***Production Continuity (Compliance and Quality System)*** * Prevent line stoppages due to incomplete or discrepant materials. * Coordinate priorities using FIFO methodology and priority reporting. * Ensure proper management of C\-Hold orders without affecting overall productivity. * Guarantee that area activities comply with Good Manufacturing Practices (GMP) and ISO 13485\. * Properly manage deviations related to materials, documentation, or traceability. ***Control and Risk Management*** * Ensure integrity of electronic systems (AS400, scanning system, MPower, and SAP). * Ensure visual, electronic, or administrative controls that reduce human error. * Implement preventive controls for handling critical components (expiration, temperature, rework). * Ensure BOM and DHR integrity from an operational perspective. ***Operational Planning and Scheduling*** * Coordinate work order prioritization based on priority reporting and FIFO methodology. * Ensure continuous flow between warehouse, setup, and production. * Prevent line stoppages resulting from incomplete or discrepant materials. ***Leadership and Continuous Improvement*** * Lead and develop technical competencies of the Setup team. * Cultivate a culture of operational discipline and accountability. * Promote a culture of continuous improvement. * Evaluate performance of direct reports. ***Key Performance Indicators (KPIs and KBIs)*** * Production schedule adherence (%) * Average setup time per order * Line stoppage incidents attributable to Setup * % Orders released without discrepancies * Setup inventory accuracy * Reduction of C\-Hold orders due to operational causes * Audit results (findings related to Setup) **Education:** * Completed bachelor’s degree, preferably in industrial engineering, mechatronics, and/or logistics. * 2–5 years of experience. * Basic conversational English. **Skills and Competencies:** ***Technical Skills:*** * Experience managing DHR, BOM, and ERP systems (AS400, SAP, MPower, or similar). * Proficiency in Office software. * Experience supervising operational staff. * Experience with scanning systems and electronic inventory control systems. ***Leadership and Strategic Competencies:*** * Operational team leadership * Compliance-based decision making * Interdepartmental communication * Priority and performance management Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
