Production Lead

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