Job descriptionExperience • 12–18 years of manufacturing operations experience within Medical Devices, Pharmaceuticals, Biologics, or regulated healthcare manufacturing. • Significant experience leading assembly and packaging operations. • Proven experience managing high-performing manufacturing teams in a cGMP-regulated environment. • Demonstrated success in regulatory inspections and quality systems. • Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement. Education • Bachelor's degree in engineering. • Master's degree preferred. Key Responsibilities Manufacturing Operations Leadership • Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and efficient manufacturing. • Own daily manufacturing performance with complete accountability for delivery commitments, quality, productivity, and cost. • Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity. • Ensure quarterly business deliverables and operational KPIs are consistently achieved. Delivery Excellence & Operational Ownership • Take complete ownership for manufacturing schedules and customer delivery commitments. • Establish and monitor operational KPIs including: o On-Time Delivery o Schedule Adherence o Overall Equipment Effectiveness (OEE) o Productivity o First Pass Yield o Right First Time o Packaging Efficiency o Training Compliance o Quality Metrics • Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply. Quality, Compliance & GMP Leadership • Champion a strong quality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements. • Ensure all manufacturing documentation is accurate, complete, and inspection-ready. • Maintain continuous audit preparedness for internal, customer, and global regulatory inspections. • Ensure compliance with applicable medical device quality standards and regulatory expectations. • Promote "Quality First" and "Right First Time" manufacturing practices across the organization. Process Excellence & Continuous Improvement • Drive continuous improvement initiatives focused on: o Defect reduction o Cycle time improvement o Cost optimization o Productivity enhancement o Waste elimination o Process standardization • Conduct process capability analysis for development and commercial products. • Recommend and implement improvements in manufacturing processes, equipment, layouts, and workflows. • Lead verification and validation activities for process changes where applicable. Cross Functional Collaboration • Work closely with: o Engineering & Maintenance o Quality Assurance o Quality Control o Supply Chain o Warehouse o Validation o Regulatory Affairs o Manufacturing Science & Technology (MSAT) • Ensure timely closure of cross-functional actions impacting manufacturing performance. • Support product transfers, process improvements, equipment qualification, and new product introductions.
