Production Lead

SITE Staffing Inc.; Oak Creek (WI); On-site; USD 65,000 - 100,000; Full time

Job summary

SITE Staffing Inc. is seeking a Floor Supervisor for our medical device manufacturing partner in the United States. The role oversees daily production on the floor to ensure safety, quality, and productivity targets are met in line with FDA, ISO 13485, and internal quality-system requirements.

You will lead operators, coordinate workflow, and ensure compliant documentation. The position emphasizes training, performance feedback, and collaboration with Quality, Engineering, and Supply Chain to

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.

Skills

Leadership

Communication

Problem solving

Reading drawings

Tools

ERP/MES systems (SAP, Oracle, etc.)

Job description

Job Summary:

The Floor Supervisor oversees daily production activities on the manufacturing floor to ensure safety, quality, and productivity targets are met in compliance with FDA, ISO 13485, and internal quality‑system requirements. This role leads operators, coordinates workflow, resolves production issues, and ensures that all documentation and processes meet regulatory standards.

Essential Functions:

• 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.
• Conducts safety checks and support incident investigations.
• Maintains a clean, organized, and audit‑ready production area.
• Identifies bottlenecks, waste, and processes inefficiencies.
• Supports Lean, 6S, and Kaizen initiatives.
• Provides feedback to engineering on equipment, tooling, and processes improvements.
• Collaborate with Engineering, Quality, Supply Chain, and Warehouse to support NPI, process optimization, and material supply.
• Report production KPIs including output, efficiency, yield, cost, and quality.
• Ensure EHS compliance; eliminate safety risks and maintain a safe working environment.

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.

Preferred but not required Qualifications:

• Experience supervising cleanroom operations.
• Familiarity with ERP/MES systems (SAP, Oracle, etc.).
• Knowledge of Lean Manufacturing tools (5S, root‑cause analysis, standard work).
• Experience supporting audits or regulatory inspections.
• Strong problem‑solving and critical‑thinking skills
• High attention to detail and documentation accuracy
• Ability to work cross‑functionally in a fast‑paced environment
• Commitment to patient safety and product quality