GMP/ISO Regulated Production Floor Lead

SITE Staffing Inc.; Oak Creek (WI); On-site; USD 55,000 - 75,000; Full time

Job summary

SITE Staffing Inc. is hiring a Floor Supervisor to oversee daily manufacturing activities on the floor, ensuring safety, quality, and productivity targets are met in compliance with GMP, ISO 13485, and FDA regulations.

You will lead operators, coordinate workflow, address production issues, and ensure documentation and processes meet regulatory standards while driving continuous improvement and team development.

Qualifications

• 3+ years of experience in manufacturing, ideally medical device, pharma, aerospace, or other regulated industries.
• 1+ year of leadership or lead-operator experience.
• Strong understanding of GMP, ISO 13485, and FDA-regulated production.
• Ability to read and interpret work instructions, SOPs, and basic technical drawings.
• Excellent communication, problem-solving, and decision-making skills.
• Ability to work on-site in a manufacturing environment.

Responsibilities

• Assigns work, balances labor, and adjusts staffing to meet schedule demands.
• Monitors production output, cycle times, scrap, and efficiency metrics.
• Ensures adherence to work instructions, SOPs, and validated processes.
• Supports start-up, changeover, and shutdown activities.
• Enforces GMP, GDP, and cleanroom/controlled-environment requirements.
• Ensures accurate completion of Device History Records (DHRs) and production documentation.
• Escalates and documents nonconformances; supports NCR investigations.
• Partners with Quality to address inspection failures, deviations, and process issues.
• Ensures operators follow proper inspection, handling, and traceability procedures.
• Be responsible for team member training and competency development, implementing initiatives to reduce employee turnover.
• Conducts performance feedback and support skill development.
• Promotes a culture of accountability, safety, and continuous improvement.
• Addresses attendance, behavior, and performance issues promptly.
• Enforces safety policies and ensure proper use of PPE.
• Reports production KPIs including output, efficiency, yield, cost, and quality.
• Ensures EHS compliance; eliminate safety risks and maintain a safe working environment.

Skills

Leadership

Communication

Problem solving

Reading technical drawings

Tools

SAP

Oracle

Job description

SITE Staffing Inc. is hiring a Floor Supervisor to oversee daily manufacturing activities on the floor, ensuring safety, quality, and productivity targets are met in compliance with GMP, ISO 13485, and FDA regulations.

You will lead operators, coordinate workflow, address production issues, and ensure documentation and processes meet regulatory standards while driving continuous improvement and team development.