Plant Head

14 hours ago


Rajkot, India MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd. Full time

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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