Medical Device Production Lead

Erbe Elektromedizin GmbH; Tempe, Northern (AZ, KY); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Erbe Elektromedizin GmbH in Tempe, AZ is seeking a skilled Lead Operator to oversee daily production activities in a medical device manufacturing environment. You will manage production staff, coordinate workflow, and ensure adherence to FDA, ISO 13485 and GMP requirements while delivering safe, high-quality devices.

The role requires strong leadership, hands-on supervision of the production line, ongoing training, and collaboration with Quality Assurance to investigate non-conformances and

Qualifications

• High School Diploma or equivalency.
• 7+ years of Lead Operator experience in manufacturing or equivalent.
• 6+ MRP/ERP experience.
• 6+ years of clean room experience.
• Medical device industry or regulated industry experience.
• Experience following work instructions, process documentation, and procedures to ensure safe working conditions.
• Team-driven attitude to work together and support TPM/5S initiatives.
• Ability to complete production paperwork including inventory.
• Excellent decision-making and problem-solving skills.
• Strong organizational skills.

Responsibilities

• Oversee and supervise daily production line activities.
• Ensure production schedules are met efficiently and on time.
• Maintain adherence to FDA, ISO and GMP standards and company policies.
• Monitor production performance and address deviations.
• Train, mentor and manage production staff for safety and quality.
• Ensure staff are trained on equipment, processes, and safety protocols.
• Collaborate with Quality Assurance to investigate non-conformances and implement corrective actions.
• Maintain accurate production records and inventory documentation.

Skills

Leadership

Production supervision

Regulatory compliance

Documentation

MRP/ERP

Clean room

Microsoft Office

Manufacturing software

Problem solving

Communication

Education

High School Diploma or equivalency

Tools

ERP system

Job description

Erbe Elektromedizin GmbH in Tempe, AZ is seeking a skilled Lead Operator to oversee daily production activities in a medical device manufacturing environment. You will manage production staff, coordinate workflow, and ensure adherence to FDA, ISO 13485 and GMP requirements while delivering safe, high-quality devices.

The role requires strong leadership, hands-on supervision of the production line, ongoing training, and collaboration with Quality Assurance to investigate non-conformances and