- Supervise and lead a team of manufacturing personnel.
- Foster a culture of excellence, teamwork, and adherence to GMP (Good Manufacturing Practices) and regulatory standards.
- Monitor and manage all manufacturing processes and equipment to ensure they operate efficiently (OEE) and in compliance with quality standards.
- Develop and maintain production schedules, ensuring that production targets and timelines are met.
- Address any production issues promptly and implement effective solutions.
- Ensure that the production of medical devices meets or exceeds all quality and regulatory standards.
- Implement and maintain rigorous quality control measures and inspections to minimize defects and ensure product integrity.
- Ensure strict adherence to FDA and other relevant regulatory requirements in the production of medical devices.
- Collaborate with quality, maintenance, and engineering teams to maintain and improve product quality, equipment efficiency, and compliance.
- Enforce and continually improve safety protocols to provide a safe working environment for all employees.
- Investigate and report any accidents or safety violations, implementing corrective actions as needed.
- Monitor and control production costs by optimizing resource utilization and minimizing waste.
- Maintain accurate records, reports, and documentation related to production, quality, and compliance.
- Provide regular reports to senior management on production metrics and KPIs.
- Identify opportunities for process improvement and efficiency enhancement.
- Develop and implement strategies to increase productivity, reduce costs, and enhance the overall efficiency of the manufacturing operations.
- Train, mentor, and develop staff to ensure they meet the highest standards of performance and compliance.
- Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Qualifications:
- Bachelor's degree in a relevant field (e.g., Operations Management, Engineering)
- 7 years of experience in manufacturing operations, with 3+ years in leadership roles.
- Knowledge of GXP manufacturing processes, quality control, and regulatory compliance, required.
- Strong leadership and communication skills.
- Excellent problem-solving and decision-making abilities.