Quality Engineer

Imagine 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 irco.com 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 the electronic QMS (e.g., MasterControl) to ensure data integrity and efficient processes.

- Own and maintain QMS processes, including document control, change management, and quality record retention, ensuring compliance with FDA, ISO, and internal requirements.

- Develop and maintain procedures and work instructions within the electronic QMS (e.g., MasterControl), ensuring clarity, accuracy, and alignment with operations.

- Review and approve change control requests, ensuring proper evaluation of product and process impact.

- Oversee calibration program, ensuring equipment control, timely execution, and resolution of out-of-spec conditions.

- Lead implementation and continuous improvement of QMS systems and tools, including MasterControl modules.

- Support New Product Introduction (NPI) by ensuring compliance with required deliverables, including validation protocols/reports (IQ/OQ/PQ), statistical analysis, risk management, customer specifications, and regulatory requirements.

- Partner with Engineering on sustaining manufacturing activities, ensuring compliance with change control, equipment/tooling maintenance, and revalidation while driving process improvement and risk reduction.

- Perform Device History Record (DHR) reviews as required, ensuring accuracy, completeness, and timely product release; identify trends and drive improvements in right-first-time performance.

- Lead or support investigations for nonconformances and CAPA, including root cause analysis and effectiveness verification.

- Participate in risk management activities, including risk assessments and pFMEA, ensuring appropriate mitigation strategies.

- Ensure effectiveness and compliance of the QMS training program, including onboarding and role-based training, in collaboration with functional leaders and HR.

- Lead and support internal audits and external audits (customer, ISO, FDA), ensuring audit readiness and timely closure of observations.

- Represent Quality in customer and supplier interactions, including audits, meetings, and regulatory/customer requests.

- Support Supplier Quality activities, including supplier qualification, Approved Supplier List maintenance, and supplier performance monitoring.

- Support cross-site alignment and business initiatives, ensuring consistency of quality processes (including Chicago/Elastomer BU).

- Assist with additional quality and engineering projects as assigned.

- Promote a culture of quality, continuous improvement, and proactive risk management.

- Bachelor's degree (BA/BS) in Engineering, Quality, Life Sciences, or a related technical field

- 1-3 years of experience in Quality Engineering, Quality Systems, or a similar role within a medical device or regulated manufacturing environment

- 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 MasterControl or similar preferred

- Strong technical writing and documentation skills, including development and revision of SOPs, work instructions, validation documents, and quality records

The pay range for this role is $65-80k. The pay range considers a wide range of factors that include a candidate's skills; experience and training; licensure and certifications; and geographic location.