Quality Engineer: NPI, CAPA & QMS Leader

Ingersoll Rand; East Chicago (IN); On-site; USD 65,000 - 80,000; Full time

Job summary

Ingersoll Rand is seeking a Quality Engineer in Alsip, IL to ensure products, processes and the Quality Management System meet regulatory requirements. The QE will own the QMS, manage document control and training, and collaborate with Engineering and Manufacturing to support New Product Introduction and sustaining operations.

Key duties include approving change controls, calibration programs, CAPAs, risk management, process validation, and internal audits.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field.
• 1+ years of experience in Quality Engineering or Quality Systems in regulated manufacturing.
• Knowledge of SPC strategies.

Responsibilities

• Own and maintain the Quality Management System (QMS), including document control, change management, quality records, electronic QMS (e.g., Master Control), and training, ensuring compliance with FDA, ISO, and internal requirements.
• Review and approve change controls; oversee calibration and equipment control programs; and drive continuous improvement of QMS processes and systems.
• Support New Product Introduction (NPI) by ensuring compliance with validation (IQ / OQ / PQ), risk management, statistical analysis, customer specifications, and regulatory requirements.
• Partner with Engineering to support sustaining manufacturing, change control, equipment maintenance, revalidation, and process improvement initiatives.
• Perform Device History Record (DHR) reviews; lead or support investigations for nonconformances and CAPAs; and drive root cause analysis, corrective actions, and right-first-time improvements.
• Lead risk management activities, including risk assessments and pFMEA, and ensure effective mitigation strategies.
• Lead and support internal, customer, ISO, and FDA audits; represent Quality in customer and supplier interactions; and support supplier qualification and performance monitoring.
• Support cross-functional and cross-site quality initiatives, special projects, and foster a culture of quality, compliance, continuous improvement, and proactive risk management.
• Implement and maintain SPC strategy for manufactured products.
• Perform Process Capability Studies (Cp,Cpk) for manufactured products.

Skills

SPC knowledge

Quality engineering

Root cause analysis

Document control

Education

Bachelor's degree in Engineering, Quality, Life Sciences, or related field

Tools

Master Control

Job description

Ingersoll Rand is seeking a Quality Engineer in Alsip, IL to ensure products, processes and the Quality Management System meet regulatory requirements. The QE will own the QMS, manage document control and training, and collaborate with Engineering and Manufacturing to support New Product Introduction and sustaining operations.

Key duties include approving change controls, calibration programs, CAPAs, risk management, process validation, and internal audits.