Quality Engineer
Listed on 2026-09-27
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager
Ingersoll Rand is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
Job title:Quality Engineer
Location:Alsip, IL
About UsImagine a company with technology leadership of over 160 years, yet it operates with the energy of a startup. Ingersoll Rand has dedicated itself to Making Life Better for its employees, customers, shareholders, and planets. We produce innovative and mission-critical flow creation and life science technologies - from compressors to precision handling of liquids, gasses, and powers - to increase industrial productivity, efficiency, and sustainability.
Supported by over 80+ brands, our products are used in various end-markets including life sciences, food and beverage, clean energy, industrial manufacturing, infrastructure, and more. Across the globe, we're driving growth with an entrepreneurial spirit and ownership mindset. Learn more at and join us to own your future.
The Quality Engineer ( QE ) ensures that products, manufacturing processes, and Quality Management System ( QMS ) activities meet established quality standards and regulatory requirements. This role combines technical quality engineering with ownership of key QMS processes, including document control, training, record management, and audit readiness. The QE works cross-functionally with Engineering, Manufacturing, and other teams to support New Product Introduction ( NPI ) and sustaining operations, ensuring timely execution of validation, risk management, and quality deliverables.
The role is also responsible for investigating and resolving nonconformances through CAPA, driving continuous improvement, and supporting the effectiveness of electronic QMS (e.g., Master Control) to ensure data integrity and efficient processes.
- 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.
- Bachelor's degree (BA/BS) 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.
- Working knowledge of Quality Management Systems (QMS), including document control, training systems, record retention, and audit support
- Familiarity with FDA 21 CFR Part 820 and ISO 13485 requirements
- Experience with electronic Quality Management Systems ( eQMS ) such as Master Control or similar preferred
- Strong technical writing and documentation skills, including development and revision of SOPs, work…
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