Production Supervisor

Plastikon Healthcare is looking for a Production Supervisor (3rd Shift) to supervise and coordinate the activities of direct and indirect personnel who are involved in one or more productions tasks. Track, monitor and follow-up the production schedule to achieve production forecast within the estimated production performance indicators such as safety, quality, cost, material management and people wellbeing. Execute manufacturing and planning strategies, methodologies, and variety of projects to optimize the production internal supply chain, on-time delivery, process transformation, performance, and systems availability. Directly responsible for production inventory and cycle count reports, material shortage, internal, external calibrations, and maintenance plan to balance production workload in conjunction with maintenance department. Direct leader on lean manufacturing methodologies such as 5S’s, production or manufacturing execution system, follows the designated procedures and policies applied by Plastikon Healthcare.

Essential Functions:

• Responsible for plant operational objectives assuring quality of products as per assignment by the management team or general manager.
• Assure compliance to all manufacturing and quality standards such as ISO13485, QSR, and cGMP’s.
• Direct responsible for all production and quality records (MBR/MPR), assuring all information is correct and is being completed contemporaneously.
• Track all quality trends to create solid and robust action plans, take ownership of all production/manufacturing complaints, NCR/CAPA champion.
• Analyze production schedule to estimate manpower hours, materials and all resources required to execute the manufacturing program.
• Manage, allocate and distribute all manufacturing line personnel in alignment with production schedule and workload balance.
• Plan and lay out work to meet production and schedule requirements.
• Keep all manufacturing line balance with support from engineering team.
• Manage absenteeism, shift/area changes, disciplinary actions, PTO, holydays, and sick days in accordance to Plastikon Healthcare policies.
• Manage payrolls for all direct reports and any additional staff assigned to provide all information required to human resource department.
• Manage personal performance evaluations to develop career path.
• Provide and support training to manufacturing personnel, create training material as required.
• Support all engineering activities such as process validation runs and plant operational projects.
• Collaborates with operational personnel (line leader, process technicians, engineering, and maintenance technicians, etc.), in monitoring and supporting the production plan.
• Conduct process control activities/projects, based on the operations SOP, taking into consideration the performance and scrap of the process.
• Assuring all process technicians creates work orders for machinery and equipment.
• Consult the technical manual to support troubleshoot problems with manufacturing equipment, process, machinery making improvements.
• Plan and lay out work to meet production and schedule requirements.
• Create records and support the process sustainability to maintain positives trends on all operational KPI’s.
• Create daily operational KPI’s reports from assigned areas as part of standard job.
• Lead 5’s and lean methodologies in accordance to the best manufacturing practices.
• Assure the quality of the product by following the cGMP and Plastikon Healthcare Policies.
• Follow the escalation path and communication process to solve process, people, and machinery issues.
• Participate in any site or company activity or special assignment by the management team or general manager.
• Support the continuous improvement.
• Follow the cGMP’s as per the quality manual to assure compliance with all applicable systems and regulations by keeping all logbooks, procedures, and standards up to date in accordance with Plastikon Healthcare Policies. Keep legible records, assuring a 100% compliance in accordance with ISO13485, cGMP and cGDP.
• Other duties as assigned.

Education/Experience:

Minimum Requirements:

• Degree in Engineering, business administration or similar
• 5 years' Experience in a GMP Pharmaceutical, Medical Device, or related facility.

Skills/Qualifications:

• Manage and application with LOTO
• 5’s applied to daily basis job
• Changer Overs (SMED)
• Basic Knowledge on Measurements Tools and Techniques
• Preventive Maintenance
• Total Predictive Maintenance
• IQMS
• Microsoft office – advanced skills for reporting and creating presentations.
• Time availability to work with different shifts.
• Previous experience with ISO 13485 and QSR.
• Previous experience with FDA cGMP’s.
• Quality systems training.
• Lean manufacturing.
• Lean six sigma.
• Experience in supply chain systems.
• Experience with inventory management.
• 5’s applied to daily basis job.
• APICS training or previous experience is a plus.
• Previous experience with ERP systems.
• Detail Oriented & Service Oriented.