Production Line Team Leader

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POSITION SUMMARY:The Production Line Team Leader is responsible for coordinating and leading daily manufacturing activities to ensure safe, efficient, and compliant production of medical devices. This role supports production goals related to quality, delivery, cost, and safety while ensuring adherence to applicable regulatory requirements (FDA, ISO 13485, GMP) and company policies. The Team Leader provides hands-on leadership to production associates and serves as a key link between operators, supervisors, and support functions. DUTIES AND RESPONSIBILITIES: Lead and coordinate daily production line activities to meet production schedules and quality standards.

Ensure compliance with Good Manufacturing Practices (GMP), ISO 13485, FDA regulations, and internal procedures. Monitor line performance, identify issues, and implement corrective actions to minimize downtime and defects. Train, coach, and support production associates on standard work, safety practices, and quality requirements. Verify proper documentation, including batch records, travelers, and production logs, ensuring accuracy and completeness. Enforce safety policies and promote a culture of safety, quality, and continuous improvement. Participate in root cause analysis and continuous improvement initiatives (Lean, Kaizen, 5S).

Communicate production status, issues, and improvement opportunities to supervisors and cross-functional teams (Quality, Engineering, Maintenance). Support audits, inspections, and internal assessments as required. Ensure proper use and care of equipment, tools, and materialsESSENCIAL REQUIREMENTS: High School Diploma required. Minimum of 2–4 years of experience in a manufacturing environment. Proven experience leading production teams in a manufacturing environment, including assigning daily work, coordinating production activities, training and coaching employees, monitoring performance, and ensuring compliance with safety, quality, and production standards.

Demonstrated ability to motivate, guide, and develop production associates while fostering a positive and accountable team environment. Strong knowledge of manufacturing processes in a regulated environment. Ability to read, understand, and follow written procedures, work instructions, and production documentation. Strong communication, organizational, and problem-solving skills. Ability to work in a fast-paced production environment, prioritize multiple tasks, and make sound day-to-day operational decisions. Experience in the Medical Device, Pharmaceutical, or other regulated manufacturing industry.

Knowledge of Lean Manufacturing, Kaizen, or 5S methodologies. English Level B1 PHYSICAL DEMAND: While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Typical Production Environment Fast paced environment Work evening and weekend as necessary TRAVEL REQUIREMENT: Occasional Travel (0–20%) Travel is rare and usually for special events, training, or annual meetings. Temporary/Transition Work (During OPERATIONS Ramp-Up) Temporary Task(s): Moving tables and miscellaneous production equipment Setting up work stations for ergonomics and time studies Rationale – Why This Role Should Support These Tasks: Support may be needed to move/reorganize manufacturing structures, equipment, and other supporting appurtenances as the early manufacturing activities are established The initial line setup will require fine tuning on-site.

Employees may be a part of establishing final placement of materials and tooling to ensure ergonomic and efficient designs. English-A2