Job Title: Production Supervisor

Location: Irvine, CA

Duration: 9 Months

Shift: 5:00 AM – 1:30 PM or 2:00 PM - 10:30 PM

Job Summary:

We are seeking an experienced Production Supervisor to oversee non-exempt manufacturing personnel in the final assembly of medical devices . The ideal candidate will manage day-to-day operations, ensure efficiency, and drive continuous improvement in manufacturability, ergonomics, and testing while ensuring compliance with industry regulations and quality standards.

Key Responsibilities:

• Supervise and coordinate daily activities of manufacturing personnel in medical device assembly .
• Provide input on manufacturability, ergonomics, process improvements, and capacity planning .
• Oversee production workflows, ensuring adherence to FDA, ISO 13485, GMP, and GDP compliance standards.
• Manage department operations within budget constraints.
• Support routing optimization, test improvements, and validation activities to enhance efficiency.
• Conduct root cause analysis (RCA) and implement corrective/preventive actions (CAPA).
• Ensure compliance with quality systems, work instructions, and standard operating procedures (SOPs) .
• Utilize Lean Manufacturing, Six Sigma, and process improvement methodologies to optimize production.
• Be willing to work a 2nd shift as needed .

Technical Skills & Qualifications:

• 4+ years of supervisory experience in a medical device manufacturing environment .
• Bachelor’s degree in Business, Engineering, or a related field .
• Knowledge of FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP/GDP) .
• Experience with process validation (IQ/OQ/PQ), risk management (FMEA), and CAPA investigations .
• Familiarity with ERP/MRP systems (SAP preferred) for production planning and inventory control.
• Proficiency in Lean Manufacturing, Six Sigma, and continuous improvement methodologies .
• Strong leadership, problem-solving, and communication skills.
• Ability to coordinate cross-functional activities and drive process improvements .