Quality Engineer: QMS, CAPA & NPI Focus

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

Job summary

Ingersoll Rand is seeking a Quality Engineer to ensure products, processes, and QMS activities meet quality and regulatory standards. The role collaborates with Engineering and Manufacturing to support NPI, validation, risk management, and CAPA execution.

The ideal candidate will own QMS documentation, participate in audits, and drive data-driven improvements using SPC tools. A bachelor’s degree and 1+ year in quality within a regulated environment are required.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, or related field.
• 1+ year in Quality Engineering within a regulated manufacturing environment.
• Experience with FDA 21 CFR Part 820 and ISO 13485 is beneficial.

Responsibilities

• Own and maintain the Quality Management System (QMS) and training programs.
• Review change controls, calibration programs, and drive QMS improvements.
• Support NPI with validation, risk management, and regulatory compliance.
• Lead investigations for nonconformances and CAPAs; perform root-cause analyses.
• Lead audits and support supplier qualification and performance monitoring.
• Implement SPC and Cp/Cpk studies for manufactured products.

Skills

Quality engineering

GxP compliance

Documentation skills

Microsoft Office

Auditing

Education

Bachelor's degree

Tools

MasterControl/eQMS

Job description

Ingersoll Rand is seeking a Quality Engineer to ensure products, processes, and QMS activities meet quality and regulatory standards. The role collaborates with Engineering and Manufacturing to support NPI, validation, risk management, and CAPA execution.

The ideal candidate will own QMS documentation, participate in audits, and drive data-driven improvements using SPC tools. A bachelor’s degree and 1+ year in quality within a regulated environment are required.