Production Floor Lead (GMP/ISO 13485, Lean)

Angel Aligner; Oak Creek (WI); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive base salary and benefits

Job summary

Angel Aligner is seeking a Floor Supervisor to oversee daily production on the manufacturing floor, ensuring safety, quality, and productivity targets are met in compliance with FDA, GMP, ISO 13485, and internal quality systems. The role leads operators, coordinates workflow, resolves issues, and ensures documentation meets regulatory standards.

You will monitor output, cycle times, scrap, and efficiency; enforce SOPs; support start‑up, changeover, and shutdowns; train team members; and partner

Qualifications

• 3+ years of manufacturing experience, preferably in regulated industries.
• 1+ year of leadership or lead-operator experience.
• Strong knowledge of GMP, ISO 13485, and FDA-regulated production.
• Ability to read and interpret work instructions and basic technical drawings.

Responsibilities

• Assigns work and balances labor to meet schedule demands.
• Monitors production output, cycle times, scrap, and efficiency metrics.
• Ensures adherence to SOPs, work instructions, and validated processes.
• Supports start-up, changeover, and shutdown activities.
• Enforces GMP, GDP, and cleanroom/controlled-environment requirements.
• Ensures documentation like Device History Records (DHRs) is accurate.
• Escalates and documents nonconformances; supports investigations.
• Partners with Quality to address inspection failures and process issues.
• Ensures operators follow inspection, handling, and traceability procedures.
• Provides training and development to team members; reduces turnover.
• Drives safety, accountability, and continuous improvement culture.
• Addresses attendance, behavior, and performance promptly.
• Maintains audit-ready production areas; conducts safety checks.

Skills

Leadership

Communication

Problem solving

Reading drawings

Tools

ERP/MES systems

Job description

Angel Aligner is seeking a Floor Supervisor to oversee daily production on the manufacturing floor, ensuring safety, quality, and productivity targets are met in compliance with FDA, GMP, ISO 13485, and internal quality systems. The role leads operators, coordinates workflow, resolves issues, and ensures documentation meets regulatory standards.

You will monitor output, cycle times, scrap, and efficiency; enforce SOPs; support start‑up, changeover, and shutdowns; train team members; and partner