Plant Head - Medical Device

Job Summary:

The Plant Head will be responsible for overall management, planning, and control of plant operations

efficiency, cost control, and on-time delivery

Key Responsibilities:1. Strategic Planning & Operations Control

• Lead day-to-day plant operations to achieve monthly and annual production targets.
• Develop and implement production plans based on demand forecasts and export schedules.
• Monitor KPIs for

  OEE, productivity, yield, downtime, rejection, and delivery performance.

• Optimize production planning, batch scheduling, and resource allocation to minimize bottlenecks.

2. Quality, Regulatory & Compliance

• Ensure strict adherence to

  ISO 13485:2016, CE, MDR, and GMP

  standards across all processes.
• Collaborate with QA and QC to maintain product quality, conduct internal audits, and resolve non-conformities.
• Maintain full traceability and documentation for batch manufacturing, sterilization, and packaging.
• Support internal and external audits (MOH, clients, notified bodies).

3. Team Leadership & Development

• Lead a multidisciplinary team across

  Production, QA/QC, Maintenance, Purchase, Store, and HR

  .
• Define departmental KPIs and conduct regular performance reviews.
• Train and motivate employees to ensure accountability, productivity, and safety compliance.
• Foster a culture of teamwork, discipline, and continuous learning.

4. Cost & Efficiency Management

• Monitor manufacturing costs, wastage, and material utilisation to improve profit margins.
• Implement Lean Manufacturing, Kaizen, and 5S principles for continuous improvement.
• Review cost sheets, BOM accuracy, and process efficiency for cost optimisation.

5. Maintenance & Facility Management

• Oversee preventive and breakdown maintenance of machinery, utilities, AHUs, and ETO sterilisation units.
• Ensure uninterrupted production through effective maintenance planning.
• Coordinate for calibration, validation, and facility upkeep as per GMP norms.

6. Production Documentation & Traceability

• Ensure timely Flow of

  BMR (Batch Manufacturing Record), BPR (Batch Packaging Record)

  , and other production documents.
• Maintain full traceability from raw material to dispatch.
• Coordinate with QA for change control, deviation, CAPA, and process validation.

7. Safety, Environment & Compliance

• Ensure implementation of

  EHS (Environment, Health & Safety)

  standards.
• Conduct regular safety drills, equipment audits, and compliance checks.
• Maintain hygienic and controlled manufacturing environments as per cleanroom classifications.

8. Cross-Functional Coordination

• Collaborate with

  Purchase, Sales, Planning, and Finance

  to ensure smooth operations.
• Review production vs. dispatch schedules and support on-time shipment for export orders.
• Participate in management review meetings and strategic business planning.

Key Skills & Competencies:

• Strong leadership, communication, and analytical abilities.
• In-depth understanding of

  medical device manufacturing processes

  (injection molding, assembly, ETO sterilization, packaging).
• Familiar with

  ISO 13485 documentation, CE marking, and GMP

  systems.
• Sound knowledge of production planning, maintenance, inventory, and manpower management.
• Proficiency in MS Office / ERP systems.
• Decision-making and problem-solving mindset.

Qualification & Experience:

• Bachelor’s / Master’s degree in

  Engineering, Industrial Management, or Production.

• Minimum 5-10 years

  of experience in manufacturing, with at least 2

  years in a senior leadership role

  (preferably in

  medical devices, pharma, or cleanroom manufacturing

  ).
• Hands-on experience with

  ISO 13485 audits, ETO sterilization, and CE compliance

  preferred.