Quality Engineer: Compliance & Process Release

Ledgent Technology; Naperville (IL); On-site; USD 65,000 - 90,000; Full time

Job summary

Ledgent Technology in Naperville, IL, seeks a quality engineer to apply quality principles across product development and manufacturing. You will support compliance, investigations, and continuous improvement within regulated environments.

You will collaborate with engineering and operations, review NCRs and CAPAs, assist audits, and help transfer processes while developing documentation and training materials for production teams.

Qualifications

• 2-4 years of experience in quality engineering.
• Good documentation, communication and interpersonal skills.
• Basic understanding of statistical techniques.
• Experience working with lab/industrial equipment.
• Solid understanding of engineering principles.
• Strong problem-solving and analytical thinking.
• Attention to detail and adherence to quality systems.

Responsibilities

• Investigate moderately complex manufacturing quality and compliance issues.
• Review NCRs, CAPAs, ECRs and audit observations prior to release.
• Provide technical support for internal and external audits.
• Develop reports and recommendations.
• Oversee product release and disposition, MRB handling.
• Review equipment validations and asset management actions.
• Collaborate with engineering for transfers.
• Develop training materials for production and knowledge transfer.

Skills

Documentation

Communication

Interpersonal skills

Statistical techniques

Lab/Industrial equipment experience

Engineering principles

Problem solving

Attention to detail

Tools

Lab equipment

Job description

Ledgent Technology in Naperville, IL, seeks a quality engineer to apply quality principles across product development and manufacturing. You will support compliance, investigations, and continuous improvement within regulated environments.

You will collaborate with engineering and operations, review NCRs and CAPAs, assist audits, and help transfer processes while developing documentation and training materials for production teams.