> Role Objective:
A key objective of this profile is to lead and oversee end-to-end production operations, including manufacturing and packing activities within the IOL device manufacturing facility. The role focuses on ensuring efficient, compliant, and high-quality production while aligning manufacturing strategies with organizational objectives.
The AGM will drive operational excellence, cross-functional coordination, continuous improvement initiatives, and adherence to regulatory and quality standards, while ensuring optimal utilization of resources and delivery of production targets. The role will also drive plant performance through the QDCI framework (Quality, Delivery, Cost, and Continuous Improvement) to ensure sustainable operational excellence and alignment with organizational performance goals.
> Desired Candidate Profile:
- Bachelor's degree in Mechanical / Industrial / Production Engineering or Electrical Engineering.
- 1518 years of experience in manufacturing operations within the medical device or plastic processing industry manufacturing medical device components, with at least 5 years in a leadership or senior management role.
- Strong experience in cellular manufacturing environments and in-depth understanding of CNC machine operations and performance optimization.
- Experience in managing automated packing lines and high-volume production environments.
- Exposure to sterilization processes, including Steam, Gamma, and ETO sterilization.
- Strong knowledge of Quality Management Systems (QMS) and ISO 13485 standards, with familiarity with FDA regulatory requirements.
- Practical knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
- Experience in capacity planning, resource optimization, and cost management.
- Proficiency in production management systems and Microsoft Office tools.
- Strong strategic thinking, decision-making, and leadership abilities.
> Key Responsibilities:
Manufacturing Operations Management
- Oversee and manage end-to-end manufacturing and packaging operations to ensure production targets, quality standards, and regulatory compliance are consistently achieved.
- Develop and implement manufacturing strategies aligned with organizational goals and operational efficiency.
- Drive plant performance using the QDCI framework to ensure improvements in product quality, delivery reliability, cost efficiency, and continuous improvement initiatives.
Production Planning and Capacity Management
- Lead production planning, scheduling, and capacity utilization to meet customer demand and business objectives.
- Coordinate with Supply Chain, Procurement, Quality, and Engineering teams to ensure smooth production operations.
Process Optimization and Continuous Improvement
- Drive Lean Manufacturing and Six Sigma initiatives to improve productivity, reduce waste, and optimize operational performance.
- Identify and implement process improvements and automation opportunities to enhance manufacturing efficiency.
- Implement QDCI-based performance management systems to improve manufacturing performance across quality, delivery, cost, and continuous improvement metrics.
Leadership and Team Development
- Lead, mentor, and develop production managers, supervisors, and operational teams to build a high-performing workforce.
- Foster a culture of accountability, operational excellence, and continuous improvement.
Quality and Regulatory Compliance
- Ensure strict adherence to QMS, ISO 13485 standards, FDA guidelines, and regulatory requirements.
- Work closely with Quality Assurance and Regulatory teams to ensure manufacturing processes remain compliant during internal and external audits.
Health, Safety, and Environmental Compliance
- Ensure compliance with EHS (Environment, Health & Safety) standards and promote a strong safety culture within the manufacturing facility.
- Monitor safety practices and implement preventive measures to minimize workplace risks.
Cost and Budget Management
- Manage manufacturing budgets and operational costs while driving cost optimization initiatives without compromising quality or compliance.
Equipment and Technology Management
- Oversee maintenance and performance of production equipment, including CNC machines and automated packing lines.
- Drive adoption of new technologies, automation, and digital manufacturing tools to improve operational capabilities.
Performance Monitoring and Reporting
- Track and analyze key production metrics such as productivity, yield, efficiency, downtime, and quality performance.
- Monitor QDCI performance metrics including yield, OEE, production adherence, OTIF contribution, scrap levels, and cost per unit.
- Present operational reports and improvement plans to senior leadership.
> Functional Skills
- Manufacturing Operations Leadership
- Quality Management Systems (ISO 13485)
- Knowledge of Plastic Manufacturing Processes
- Regulatory Compliance and Audit Readiness
- Lean Manufacturing and Six Sigma
- Production Planning and Capacity Management
- Process Automation and Technology Implementation
- Budget and Cost Optimization
> Behavioral Skills Required
- Strong leadership and people management skills
- Strategic and analytical thinking
- Effective decision-making and problem-solving capability
- Strong cross-functional collaboration and stakeholder management
- Ability to manage complex operations in a dynamic manufacturing environment
> Team Size
- Reports to: General Manager Manufacturing & Site Incharge
- Team Structure: Managing a team of production managers, supervisors, and manufacturing staff.
> Important Links
- Website: https://biotechhealthcare.com/
- LinkedIn: https://www.linkedin.com/company/biotechhealthcare/
- Instagram: Biotech Vision Care
Learn more at: https://www.biotechhealthcare.com
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, sexual orientation, disability, etc.
