Plant Manager

Role & Responsibilities

Production Management

• Lead and oversee daily production across all departments: extrusion (PTFE & thermoplastics), machining, laser cutting, and catheter assembly.
• Ensure productivity, yield, and OEE targets are achieved.
• Drive manufacturing excellence through efficient line balancing, real-time monitoring, and bottleneck elimination.

Planning & Coordination

• Develop and implement the

  master production schedule

  based on sales forecasts and inventory requirements.
• Coordinate with supply chain and procurement teams to ensure material availability and capacity planning.
• Conduct daily/weekly production reviews and implement corrective actions as needed.

People Management

• Lead a multidisciplinary team including production supervisors, technicians, operators, and support staff.
• Ensure workforce planning, training, motivation, and performance evaluation.
• Promote a culture of discipline, accountability, and continuous improvement.

Quality & Regulatory Compliance

• Collaborate with Quality and Regulatory Affairs teams to ensure adherence to

  ISO 13485

  ,

  FDA 21 CFR Part 820

  , and

  GMP

  requirements.
• Ensure robust

  in-process inspection

  and

  traceability

  on all lines.
• Lead root cause analysis and CAPA for non-conformances or deviations.

Operational Excellence

• Drive lean manufacturing, Kaizen, 5S, and other continuous improvement initiatives.
• Oversee preventive maintenance planning for all plant equipment (extruders, laser systems, CNC, etc.).
• Implement and track production KPIs (OEE, downtime, yield, rework, etc.).

Administrative & Budgetary Control

• Prepare and manage the plants operational budget, ensuring cost control and optimal resource utilization.
• Ensure installation, commissioning, IQ/OQ/PQ of equipments as per validation requirements.
• Ensure compliance with all labor laws, safety, and environmental regulations.
• Maintain documentation, shift rosters, leave schedules, and audit readiness.

Preferred Candidate Profile

• Strategic production planning and execution
• Budgeting and Cost Control
• People leadership and conflict management
• Manufacturing KPIs and data-driven decision making
• Regulatory knowledge: ISO 13485, 21 CFR 820
• Exposure to ERP/MES systems (SAP, Oracle, Plex, etc.)
• Lean, Six Sigma, and TPM practices
• Exceptional communication and team-building skills