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