Automation Operator

Duties and responsibilities

• Operate and maintain automated production lines for medical devices
• Work in a safe manner and follow guidelines
• Work in a team in a fast-paced FDA-regulated environment
• Set up and maintain automated equipment while following Standard Operating procedures (SOPs)
• Suggest process improvements
• Perform inline QC checks to ensure quality products are being produced
• Follow cGMP processes
• Track production using batch records following GDPM
• Maintain clean and sanitary work area
• Mentor less experienced personnel in the above procedures
• Perform other duties as assigned by Management
• Work at different workstations as needed to meet production requirements

Qualifications

• High school diploma or equivalent
• 2+ years of work experience, preferably in an automated environment
• Ability to understand directions in English
• Self-starter, able to accomplish tasks with little or no supervision
• Able to prioritize workload
• Legally authorized to work in the United States
• Ability to lift to 50 lbs and work near moving mechanical parts while wearing appropriate personal protective equipment
• Ability to use caliber, hand tools, troubleshoot automation machines
• Willingness to work as a team and treat all colleagues with respect and consideration
• Base understanding and willingness to learn Kazen, 6’S, KPI, Gemba walk, SQDC (Safety, Quality, Delivery, Cost)