Production Supervisor

Summary of Position

This position is responsible for supervising manufacturing personnel to achieve daily production targets.

• Regulatory Compliance: Enforces company WIs (Work Instructions) and SOPs (Standard Operating Procedures) are followed across all manufacturing processes to follow FDA regulations and ISO 13485 quality standards.
• Quality Control: Works with Quality team to maintain company’s quality standards and track defect rates.
• Continuous Improvement: Collaborates with Engineering team to help implement lean manufacturing principles and process optimization strategies to increase yield, reduce waste, and enhance efficiency.

Primary Job Responsibilities

Position is primarily responsible for supervising the end-to-end manufacturing process of medical products, ensuring they are produced safely, efficiently, and in strict compliance with regulatory standards such as FDA and ISO 13485.

Accountability (size of responsibility)

Primary accountability is to achieve daily production targets, while complying with company GMP principles.

Qualifications

• Education: Associate’s degree in engineering, operations management, or a related field is preferred; or a minimum of +5 years of progressive experience in medical Class II device manufacturing.
• Technical proficiency: Strong supervisory capabilities, knowledge of GMP (Good Manufacturing Practices), and an understanding of process engineering.
• Certifications: Certifications such as GMP/ISO standards or Lean Manufacturing are highly preferred.

Physical Demands

• Standing for long periods of time (3-4 hours) and lifting packages up to 50 lbs.