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15h Left! Plant Head - Medical Device

15h Left! Plant Head - Medical Device

MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd.India
11 hours ago
Job description

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.
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