Medical Device Operations Director
MEDIPLUS® | Shree Umiya Surgical Pvt. Ltd.Ahmedabad, Republic Of India, IN17 days ago
Job descriptionEnsure 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). 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. 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. 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. 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. 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. 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. 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. 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 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
3. Team Leadership & Development
4. Cost & Efficiency Management
5. Maintenance & Facility Management
6. Production Documentation & Traceability
7. Safety, Environment & Compliance
8. Cross-Functional Coordination
Key Skills & Competencies :
Qualification & Experience :
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Medical Director • Ahmedabad, Republic Of India, IN
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