Quality Engineer – QMS & NPI Excellence

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

Job summary

Ingersoll Rand in Alsip, IL seeks a Quality Engineer to ensure products, processes, and QMS activities meet quality standards and regulatory requirements. You will own QMS documentation, CAPA processes, and support validation and risk management across NPI and sustaining operations.

The role requires a Bachelor's in a technical field and 1+ years in quality within regulated manufacturing. Familiarity with FDA/ISO requirements and Master Control is preferred.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or a related technical field.
• 1+ years of experience in Quality Engineering, Quality Systems, or a similar role within a medical device or regulated manufacturing environment.
• Must have knowledge and understanding 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.
• Act as Quality Manager when QM is offsite.

Skills

SPC knowledge

Quality Systems

Regulatory awareness

Education

Bachelor's degree in Engineering/Quality/Life Sciences

Tools

Master Control

Job description

Ingersoll Rand in Alsip, IL seeks a Quality Engineer to ensure products, processes, and QMS activities meet quality standards and regulatory requirements. You will own QMS documentation, CAPA processes, and support validation and risk management across NPI and sustaining operations.

The role requires a Bachelor's in a technical field and 1+ years in quality within regulated manufacturing. Familiarity with FDA/ISO requirements and Master Control is preferred.