Plant Head - Medical Device

Job Summary:

The Plant Head will be responsible for overall management, planning, and control of plant operations — ensuring optimum utilization of manpower, materials, and machinery while maintaining the highest standards of productivity, quality, safety, and regulatory compliance (ISO 13485, CE, MDR, GMP).

This role requires a strong leader who can align cross-functional teams (Production, QA, QC, Maintenance, Purchase, Stores, HR, ) toward achieving company goals in efficiency, cost control, and on-time delivery, while driving a culture of continuous improvement.

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.

Job Types: Full-time, Permanent

Pay: ₹35,000.00 - ₹75,000.00 per month

Work Location: In person