Job Description
Position: Lead 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 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.