Medical Device & Packing Operations

Experience• 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 ResponsibilitiesManufacturing 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 Deliveryo Schedule Adherenceo Overall Equipment Effectiveness (OEE)o Productivityo First Pass Yieldo Right First Timeo Packaging Efficiencyo Training Complianceo 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 reductiono Cycle time improvemento Cost optimizationo Productivity enhancemento Waste eliminationo 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 & Maintenanceo Quality Assuranceo Quality Controlo Supply Chaino Warehouseo Validationo Regulatory Affairso 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.