Senior Clean Room Operator – Medical Devices (ISO13485)

Sterling Industries; Kalamazoo (MI); On-site; USD 42,000 - 66,000; Full time

Job summary

Sterling Industries is seeking experienced Clean Room Operators for medical device manufacturing (ISO13485). The role focuses on GMP compliance, efficient use of resources, and adherence to quality standards while supporting continuous improvement initiatives.

Ideal candidates bring at least 5 years in manufacturing, strong teamwork across admin, ops, quality, and engineering, and familiarity with clean room environments. Flexibility in scheduling is preferred to meet production goals.

Qualifications

• Minimum 5 years in a manufacturing environment.
• Ability to communicate with administrative, operations, quality, and engineering teams.
• Experience with ISO13485 and clean room environment.

Responsibilities

• Ensure GMP are being followed at all times.
• Optimize use of company resources (personnel, materials, equipment) to meet budgets.
• Maintain documentation per quality management system and ISO13485.
• Perform inspections for receiving, in-process and final inspections.
• Schedule production using ERP/MRP systems to optimize resources.
• Coordinate preventative maintenance and resolve equipment issues per QMS.
• Drive continuous improvements in people, equipment, processes, products and facility.
• Minimize and resolve quality issues with the quality department.
• Maintain cleanliness of the production area and related documentation.

Skills

GMP compliance

Team communication

Continuous improvement

Flexible schedule

Manufacturing processes

Tools

ERP/MRP systems

Microsoft Office

Job description

Sterling Industries is seeking experienced Clean Room Operators for medical device manufacturing (ISO13485). The role focuses on GMP compliance, efficient use of resources, and adherence to quality standards while supporting continuous improvement initiatives.

Ideal candidates bring at least 5 years in manufacturing, strong teamwork across admin, ops, quality, and engineering, and familiarity with clean room environments. Flexibility in scheduling is preferred to meet production goals.