Quality Engineer, Site Lead

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.

Location:

Chicago, IL (onsite)

Step into a visible, hands-on role with site quality lead responsibilities where your work directly impacts product integrity, customer confidence, and manufacturing performance. The Quality Site Lead is responsible for the full range of Quality Engineering support, including quality systems, process improvement, validation, CAPA, auditing, risk assessment, training, and new product introduction support across the Elastomer Chicago manufacturing site. This role has primary ownership of ISO 9001 compliance and supports ISO 13485 medical device silicone operations as needed.

It is a strong opportunity for a quality leader who enjoys being close to production, solving problems at the root, partnering across Operations, Engineering, Purchasing, and leadership, and building a culture of accountability and continuous improvement. The position also leads Quality Technicians and Inspectors, ensuring the team is aligned, audit‑ready, and focused on consistent product quality across both industrial and medical device environments.

• Develop, maintain, and execute quality procedures and work instructions to streamline processes and ensure compliance with FDA regulations, ISO standards, and other applicable regulatory requirements.
• Oversee the development, management, maintenance, and effectiveness of the Elastomer BU Quality Management System, including ISO 9001 and ISO 13485 compliance.
• Serve as Management Representative for the Elastomer BU Chicago site.
• Ensure all SOPs and process documentation are created in accordance with the QMS and partner with departments to ensure effectiveness.
• Ensure document control and revision control activities are maintained in compliance with QMS and regulatory requirements.
• Responsible for ensuring all cleanroom requirements are met, as applicable.
• Host customer and registrar audits and coordinate or perform internal quality and supplier audits as needed.
• Lead and/or support internal and external CAPAs, NCRs, and customer complaints, including investigation, root cause analysis, corrective actions, and related documentation.
• Change Control, Documentation, and Product Release.
• Review and assess change requests to ensure proper evaluation of impact on product quality, processes, and regulatory compliance. Manage customer‑submitted change requests through completion.
• Review and approve engineering documentation, including validation protocols/reports, sample run requests, and manufacturing procedures, ensuring adherence to customer and regulatory requirements.
• Ensure all products conform to validated processes and DMRs; perform lot release and related quality functions.
• Assure reliability and consistency of production by monitoring processes and final output.
• Implement statistical tools, including SPC, MSA, and GR&R, to ensure process control and measurement system reliability.
• Leverage ISO 9001 continuous improvement principles to improve process efficiency and effectiveness. Monitor key quality metrics and provide regular reporting to leadership.
• Collaborate with Purchasing to co‑manage the Approved Supplier List and evaluate suppliers to ensure product compliance.
• Monitor supplier performance and rate suppliers through scorecard ratings.
• Provide oversight of the calibration and preventive maintenance programs to ensure compliance.
• Collaborate with cross‑functional teams to identify equipment, testing, and resource needs for new or existing products, and communicate requirements to leadership.
• Achieve quality assurance human resource objectives by recruiting, selecting, orienting, training, scheduling, coaching, counseling, and disciplining employees.
• Communicate job expectations and lead team talent and performance management processes.
• Conduct employee training sessions, as applicable.
• Maintain current quality management knowledge by studying industry trends, participating in educational opportunities, reading professional publications, and engaging in professional organizations and networking opportunities.

• Bachelor's degree ideally in industrial, mechanical / manufacturing engineering or similar field
• 5+ years of significant professional experience in continuous quality improvement with progressive scope and responsibility.
• 4+ years experience working within an ISO 9001 quality management system, including quality procedures, documentation, audits, corrective actions, and continuous improvement…