Manufacturing Operations Manager

About FiunEx

Through our unique engagement model and its success, we have experienced extremely tremendous growth in a short duration. We now have presence in US, Ireland, India and Thailand. For more details on company, visit our website at www.fiunex.com.

Position Overview

The Plant Manager will be responsible for overseeing the daily manufacturing operations, ensuring optimal production performance, cost efficiency, and compliance with quality and regulatory standards. The ideal candidate will have strong leadership skills, deep operational expertise, and experience within the medical devices or life sciences sector. Knowledge of ISO 13485 standards will be an added advantage.

Key Responsibilities

• 1. Operations Management

• Lead end-to-end manufacturing operations including production, quality, maintenance, supply chain, and EHS.

• Plan, organize, and optimize production schedules to meet demand and quality targets.

• Monitor KPIs for productivity, efficiency, and resource utilization.

• 2. Team Leadership & Development

• Manage and mentor a team of ~50 employees including supervisors, engineers, and operators.

• Foster a culture of safety, accountability, and continuous improvement.

• Identify training needs and drive skill development across teams.

• 3. Quality & Compliance

• Ensure adherence to all regulatory and quality standards, including ISO 13485.

• Collaborate with the Quality Assurance team to maintain product and process compliance.

• Support internal and external audits, CAPA implementation, and documentation control.

• 4. Process Improvement & Efficiency

• Drive lean manufacturing initiatives to reduce waste, improve cycle time, and enhance productivity.

• Implement best practices in preventive maintenance, calibration, and process validation.

• Leverage data-driven insights for operational excellence.

• 5. Budgeting & Cost Control

• Prepare and manage annual operating budgets for the plant.

• Monitor cost performance and identify areas for savings without compromising quality.

• Collaborate with procurement and logistics to ensure timely availability of materials.

• 6. Health, Safety & Environment (HSE)

• Ensure compliance with all environmental, health, and safety regulations.

• Promote a zero-incident workplace through proactive safety programs and regular training.

Required Qualifications & Skills

• Bachelor’s degree in Mechanical, Industrial, or Production Engineering (Master’s preferred).

• 10–15 years of experience in manufacturing operations, preferably in medical devices, diagnostics, or life sciences industries.

• Proven track record in leading large teams and managing plant operations.

• Working knowledge of ISO 13485, ISO 9001, and related quality management systems.

• Strong analytical, problem-solving, and decision-making abilities.

• Excellent communication, leadership, and stakeholder management skills.

• Experience implementing lean, six sigma, or similar operational excellence methodologies (certification preferred).

Preferred Attributes

• Hands-on experience with ERP systems and production planning tools.

• High energy, result-oriented leader with a focus on continuous improvement.

Compensation

Commensurate with experience and industry standards.