Manufacturing/Production Head

OptraSCAN, Inc.; Pune District; Presencial; INR 4 500 000 - 6 000 000; Tempo integral

Resumo da oferta

OptraSCAN, Inc. is seeking an experienced Manufacturing Head to lead end-to-end plant operations for our medical technology business in Pune.

You will drive production planning, quality compliance, cost control, and on-time delivery while building a high-performing team. You will partner with Quality, R&D, Engineering, Procurement, and Supply Chain to implement lean manufacturing, CAPA, NPI, and scale-up processes, ensuring GMP/ISO 13485 standards are upheld and budgets are optimized.

Qualificações

• Strong leadership in plant operations, production planning, capacity management, and team development.
• In-depth knowledge of medical-device and IVD manufacturing, including assembly, testing, packaging, labeling, traceability, and product release controls.
• Working knowledge of ISO 13485, applicable regulatory requirements, Good Manufacturing Practices, and audit-readiness expectations.
• Strong understanding of process validation, equipment qualification, manufacturing documentation, nonconformance control, CAPA, risk management, and change control.
• Experience with lean manufacturing, operational excellence, root-cause analysis, waste reduction, OEE, yield improvement, and cost optimization.
• Knowledge of supply chain coordination, inventory control, vendor management, and contract manufacturing oversight.
• Ability to support NPI, design transfer, production scale-up, and cross-functional issue resolution.
• Strong analytical, decision-making, problem-solving, communication, and stakeholder-management skills.

Responsabilidades

• Lead end-to-end manufacturing and plant operations, including production planning, assembly, testing, dispatch, and operational execution.
• Develop and implement manufacturing strategies aligned with business and production requirements.
• Manage production planning and scheduling to achieve quality, productivity, and delivery targets.
• Establish and monitor KPIs for production, quality, productivity, yield, OEE, cost, and delivery.
• Ensure compliance with applicable quality management systems, regulatory requirements, SOPs, and manufacturing standards.
• Work closely with Quality, R&D, Engineering, Procurement, Supply Chain, Service, and Commercial teams.
• Drive process improvement, lean manufacturing, waste reduction, productivity improvement, and cost optimization.
• Identify manufacturing bottlenecks and implement corrective and preventive actions.
• Ensure effective utilization of manpower, machines, materials, and plant infrastructure.
• Lead capacity planning and support new product introduction (NPI), product transfer, and manufacturing scale-up.
• Establish robust systems for process validation, production documentation, traceability, and change management.
• Manage vendors and contract manufacturing partners, wherever applicable.
• Ensure adherence to EHS and workplace safety requirements.
• Build, mentor, and lead a high-performing manufacturing and plant operations team.
• Prepare and manage manufacturing budgets, operational costs, and resource requirements.
• Drive continuous improvement initiatives across the plant.
• Participate in internal and external quality/regulatory audits and ensure timely closure of observations.
• Provide regular operational updates and manufacturing performance reports to senior management.

Conhecimentos

Leadership in plant operations

Production planning

Lean manufacturing

Quality/regulatory knowledge

CAPA/risk management

NPI/Design transfer

Cross-functional collaboration

Descrição da oferta de emprego

We are looking for an experienced Manufacturing Head / Plant Head to lead and manage end-to-end manufacturing and plant operations for our medical technology business.

The role will be responsible for ensuring efficient manufacturing operations while maintaining high standards of quality, compliance, productivity, cost control, and on-time delivery.

Key Responsibilities

• Lead end-to-end manufacturing and plant operations, including production planning, assembly, testing, dispatch, and operational execution.
• Develop and implement manufacturing strategies aligned with business and production requirements.
• Manage production planning and scheduling to achieve quality, productivity, and delivery targets.
• Establish and monitor KPIs for production, quality, productivity, yield, OEE, cost, and delivery.
• Ensure compliance with applicable quality management systems, regulatory requirements, SOPs, and manufacturing standards.
• Work closely with Quality, R&D, Engineering, Procurement, Supply Chain, Service, and Commercial teams.
• Drive process improvement, lean manufacturing, waste reduction, productivity improvement, and cost optimization.
• Identify manufacturing bottlenecks and implement corrective and preventive actions.
• Ensure effective utilization of manpower, machines, materials, and plant infrastructure.
• Lead capacity planning and support new product introduction (NPI), product transfer, and manufacturing scale-up.
• Establish robust systems for process validation, production documentation, traceability, and change management.
• Manage vendors and contract manufacturing partners, wherever applicable.
• Ensure adherence to EHS and workplace safety requirements.
• Build, mentor, and lead a high-performing manufacturing and plant operations team.
• Prepare and manage manufacturing budgets, operational costs, and resource requirements.
• Drive continuous improvement initiatives across the plant.
• Participate in internal and external quality/regulatory audits and ensure timely closure of observations.
• Provide regular operational updates and manufacturing performance reports to senior management.

Relevant Skills and Knowledge

• Strong leadership in plant operations, production planning, capacity management, and team development.
• In-depth knowledge of medical-device and IVD manufacturing, including assembly, testing, packaging, labeling, traceability, and product release controls.
• Working knowledge of ISO 13485, applicable regulatory requirements, Good Manufacturing Practices, and audit-readiness expectations.
• Strong understanding of process validation, equipment qualification, manufacturing documentation, nonconformance control, CAPA, risk management, and change control.
• Experience with lean manufacturing, operational excellence, root-cause analysis, waste reduction, OEE, yield improvement, and cost optimization.
• Knowledge of supply chain coordination, inventory control, vendor management, and contract manufacturing oversight.
• Ability to support NPI, design transfer, production scale-up, and cross-functional issue resolution.
• Strong analytical, decision-making, problem-solving, communication, and stakeholder-management skills.