SENIOR DIRECTOR

Company Overview

Role Purpose

Team Manager-MFG-DP(Fill Finish)-Med Devices, Packaging Ops and Visual Inspection-Med Devices: The management and compliance of medical devices within an organization. Responsible for ensuring all medical devices used meet regulatory standards and are integrated seamlessly into manufacturing processes. Coordinates with cross-functional teams to maintain device functionality, quality assurance, and adherence to Good Manufacturing Practices (GMP). Implements improvements and provides expertise in the selection, validation, and ongoing maintenance of medical devices critical to operational success.

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

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.
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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

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• • 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

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• • 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.