Clean Room Assembler

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

About us:Sterling Industries is a North American based contract manufacturer and assembler of medical devices and sub-components. We help clients deliver successful products by providing scaled production, design-for-manufacturing expertise, supplier consolidation and other critical value chain services.

Overview

We are seeking experienced Clean Room Operators with experience in the medical device manufacturing industry (ISO13485). The Clean Room Operator ensures optimal use of company resources (people, materials, equipment) to produce products to specification, on time, and complete to meet or exceed the expectations of our customers while improving our people, processes, and equipment.

Key Responsibilities Include:

• Ensuring GMP are being followed at all times
• Ensuring optimal use of company resources
• Responsible for meeting budgeted costs for labor, material, equipment, and other production related expenses
• Ensuring all production related processes, documentation and areas are in compliance with our quality management system and ISO13485
• Participates in performing inspections for receiving, in-process and final inspections.
• Use of ERP/MRP systems in scheduling production people, materials and equipment to ensure optimal use of company resources
• Ensuring preventative maintenance and resolution of equipment issues are performed in accordance with the quality management system
• Driving continuous improvements in people, equipment, processes, products, and the facility as per Quality Objectives and departmental activities.
• Minimizing and resolving quality issues while working in conjunction with the quality department
• Responsible for cleanliness of the production area and all related documentation

Position Requirements

• Ideal candidate has a minimum of 5 years of experience in a manufacturing environment (production, equipment, quality systems, and facility)
• Able to communicate and coordinate with administrative, operations, quality, and engineering teams
• Able to implement, and complete continuous improvement efforts
• Able to work a flexible schedule
• Has extensive working knowledge of manufacturing and process equipment
• Proficient in Microsoft Office (outlook, word, excel) an asset
• Experience in clean room environment and ISO13485 standard

J. Sterling Industries is an equal opportunity employer. If you require accommodation, please notify us and we will work with you to meet your needs.