Manufacturing Operations Associate

GQR; Georgia (VT); On-site; USD 35,000 - 55,000; Full time

Job summary

Join a forward-thinking company in the medical equipment sector, where you will play a crucial role in manufacturing and quality assurance. This full-time position offers a dynamic environment where your skills in data entry, inventory control, and environmental monitoring will shine. You will be responsible for ensuring compliance with FDA regulations and ISO standards while maintaining high-quality production processes. If you're passionate about contributing to the medical field and eager to grow in a supportive team, this opportunity is perfect for you.

Qualifications

• Entry-level position requiring a high school diploma or equivalent.
• 2+ years in manufacturing or quality roles preferred.

Responsibilities

• Issue and track Manufacturing Work Orders for accuracy.
• Conduct environmental monitoring and analyze data.
• Prepare shipments and maintain compliance with procedures.

Skills

Data Entry

Inventory Control

Quality Assurance

Environmental Monitoring

Education

High School Diploma

Tools

MRP System

Job description

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This position involves performing various operations including, but not limited to, Receiving, Receiving Inspection, Shipping, Inventory Control, Manufacturing activities, environmental monitoring, and maintenance. The individual will perform routine data entry in the MRP database, manage LHR releases, prepare shipping documentation, and ensure compliance with internal procedures, FDA Quality Systems Regulations, and ISO Standards.

Responsibilities

• Issue, track, and review Manufacturing Work Orders (LHR documentation) for accuracy and traceability.
• Manufacture and assemble products following approved procedures.
• Perform label printing, initial packaging, and final packaging as needed.
• Prepare product samples for sterilization and lot release testing.
• Conduct self-inspections on assembly work to ensure quality standards.
• Maintain a clean and organized workstation.
• Follow all safety, corporate, and production procedures.
• Perform environmental monitoring, including particulate counting and microbial testing, and analyze data from each test cycle.
• Perform other duties as assigned.

Inventory, Receiving & Distribution

• Process incoming transactions and inventory in the MRP system.
• Handle documentation related to product returns.
• Conduct periodic cycle counts and report inventory levels.
• Prepare shipments with proper documentation, complying with all procedures and export requirements.
• Review inspection documentation and perform inspections as needed.

Qualifications

• High School diploma or equivalent (entry-level).
• 2+ years’ experience in manufacturing or quality roles preferred.
• Experience in regulated environments, including compliance with FDA QSRs (21 CFR 820) and ISO 13485, is preferred.

Additional Information

• Seniority level: Associate
• Employment type: Full-time
• Job function: Manufacturing
• Industries: Medical Equipment and Pharmaceutical Manufacturing