Job Summary

The Factory Head will be responsible for overseeing all manufacturing operations of the medical technology's facility, ensuring consistent, high-quality, and compliant production. The role involves managing production, RM, FG, maintenance, and factory regulatory compliance functions. The Factory Head will drive continuous improvement, operational efficiency, and adherence to international standards such as ISO 13485, MDSAP, and GMP while fostering a strong culture of quality and safety.

Key Responsibilities

1. Plant Operations Management

- Lead the end-to-end manufacturing operations of medical technology's facility

- Ensure smooth functioning of production, moulding, assembly, packaging, maintenance, and warehouse activities.

- Achieve daily, weekly, and monthly production targets while maintaining quality, efficiency, and cost control.

- Ensure optimal utilization of plant capacity, manpower, materials, and equipment.

- Ensure timely closure of Batch Manufacturing records and MO's

- Ensure batch wise planning, tracking and completion of production.

2. Quality and Regulatory Compliance

- Ensure full compliance with ISO 13485, MDSAP, GMP, and other applicable regulatory standards.

- Oversee validation, calibration, and qualification of manufacturing processes and equipment.

- Collaborate with Quality Assurance and Regulatory Affairs teams for internal/external audits, certifications, and documentation.

- Ensure traceability, batch documentation, and data integrity across all operations.

3. Production Planning and Control

- Develop and implement production schedules aligned with business demand forecasts.

- Coordinate with procurement and supply chain teams to ensure timely availability of raw materials and components.

- Plan and Monitor inventory levels to minimize waste and optimize working capital.

4. Team Leadership and Development

- Lead, mentor, and manage a cross-functional team of production engineers, supervisors, technicians, and support staff.

- Foster a culture of accountability, continuous learning, and teamwork.

- Identify training needs and develop technical competency among staff.

5. Health, Safety, and Environmental (HSE) Management

- Enforce adherence to biosafety, environmental, and occupational health standards in the factory.

- Ensure compliance with safety protocols for handling biological materials, chemicals, and reagents.

- Conduct regular safety audits and implement corrective/preventive measures.

6. Process and Technology Improvement

- Drive process optimization initiatives using Lean, Six Sigma, and automation principles.

- Identify opportunities to improve product yield, reduce downtime, and enhance process reliability.

- Collaborate with R&D for technology transfer and scale-up of new diagnostic products.

7. Budgeting and Reporting

- Prepare and manage annual operational budgets for the factory.

- Track and report KPIs including productivity, TPS, OEE, rejection rate, and cost efficiency.

- Present regular operational performance metrics to senior management.

Qualifications and Experience

Education:

- Bachelor's / master's degree in biotechnology, Microbiology, Biochemistry, Chemical Engineering, Biomedical Engineering, or related discipline.

- MBA in Operations or Industrial Management (preferred).

Experience:

- Minimum 18 + years of experience in manufacturing, with at least 10 years in a senior leadership role in diagnostic kits, medical device, or pharmaceutical manufacturing.

- Proven experience in managing cleanroom production and quality systems under ISO 13485.

- Strong understanding of diagnostic kit components, formulation, assembly, labelling, and packaging processes.

Skills and Competencies:

- Strong leadership and team management skills.

- Deep understanding of regulatory and quality requirements for molecular diagnostic kits, medical lab blood collection tubes, syringe manufacturing.

- Excellent analytical, decision-making, and problem-solving abilities using first principles.

- Hands on proficiency in handling SAP which can be demonstrated and manufacturing data analysis.

- Strong communication and stakeholder management skills.