Plant Head (Greater Noida)

ROLE OVERVIEW

The Plant Head is a senior operations leader accountable for the end-to-end establishment and management of a greenfield medical device manufacturing facility. This role carries full P&L responsibility for the plant and ensures that all production, engineering, quality, and supply chain activities conform to global and Indian regulatory standards. The incumbent will build and lead cross-functional teams while instilling a culture of operational excellence, regulatory compliance, and continuous improvement.

KEY RESPONSIBILITIES

1. Greenfield Project Planning & Execution

Develop comprehensive project plans, timelines, and milestone schedules for the new facility.

Define project scope, objectives, and deliverables in alignment with business strategy.

Monitor progress rigorously, ensuring delivery within budget and on schedule.

Identify project risks proactively and implement mitigation strategies.

2. Production & Operations Management

Oversee end-to-end manufacturing operations for electrical medical devices.

Ensure production targets are consistently achieved in line with the production plan and customer demand.

Optimise manufacturing processes to drive productivity, efficiency, and cost control.

Monitor daily operations, resolve challenges swiftly, and maintain uninterrupted throughput.

3. Regulatory Compliance

Ensure plant-wide compliance with all applicable standards and regulations, including:

ISO 13485 — Medical Device Quality Management System

Indian MDR 2017 and BIS Standards

IEC 60601, IS/IEC 80601-02, IS 13450, IS 11378 series for electrical medical devices

Good Manufacturing Practices (GMP)

Accountabilities include supporting regulatory audits and inspections, and maintaining complete Technical Documentation / Technical Construction Files (TCF).

4. Quality Management

Lead strict implementation and continuous improvement of the Quality Management System (QMS).

Partner with QA/QC teams to ensure robust product quality control.

Oversee non-conformance management, CAPA processes, and deviation resolution.

Ensure all products are tested to applicable standards and customer specifications.

5. Engineering & Maintenance

Direct engineering and maintenance teams to ensure facility readiness and uptime.

Ensure all manufacturing equipment is properly maintained and calibrated per schedule.

Champion improvements in production technology, automation, and process capability.

6. Supply Chain & Inventory Management

Monitor raw material availability and coordinate closely with approved vendors.

Maintain rigorous control of inventory across raw materials, WIP, and finished goods.

Collaborate with procurement and logistics teams to prevent supply disruptions.

7. Team Leadership & People Development

Lead and inspire cross-functional teams spanning Production, Maintenance, Engineering, Stores, and Supply Chain.

Provide structured training, coaching, and performance guidance to direct reports and wider teams.

Conduct periodic performance reviews and implement talent development plans.

8. Continuous Improvement

Drive Lean manufacturing practices across all production areas.

Identify and implement initiatives to improve product quality and reduce process cycle time.

Systematically reduce production defects, scrap, and wastage.

9. Documentation & Reporting

Ensure accurate and timely maintenance of all production records (BMR / DHR).

Oversee equipment maintenance logs, calibration records, and production planning reports.

Provide regular management reports on plant performance, quality KPIs, and compliance status.

QUALIFICATIONS & EXPERIENCE

Bachelor's or Master's in:

Electrical Engineering/Electronics Engineering/Biomedical Engineering/Mechanical Engineering

10–15 years in manufacturing

Minimum 5 years in a leadership role

Experience in medical device manufacturing (preferred)

Greenfield plant setup of a medical device unit (preferred)

KEY COMPETENCIES

Technical & Functional

Deep knowledge of life-saving medical device manufacturing

IEC 60601, IS/IEC 80601-02, IS 13450 and related standards

ISO 13485 Quality Management Systems

Production planning and operations management

Regulatory compliance — MDR 2017, BIS, GMP

Engineering and maintenance management

Visionary leadership and team building

Strategic thinking and decision-making

Cross-functional collaboration and stakeholder management

Strong problem-solving under pressure

Effective communication and influencing skills

People development and performance management

High integrity and accountability