Quality Site Lead: ISO 9001/13485 Expert (Onsite, Chicago)

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, Site Lead Location : Chicago, IL (onsite) About Us 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. Job Overview : 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. Responsibilities Quality Management System / Regulatory Compliance: 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. Audits, CAPA, NCRs, and Customer Complaints: 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. Production Quality, Process Control, and Continuous Improvement: 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. Supplier Quality And Compliance: 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. Calibration, Preventive Maintenance, and Resource Planning 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. Team Leadership, Training, and Talent Management: 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. Professional Development: Maintain current quality management knowledge by studying industry trends, participating in educational opportunities, reading professional publications, and engaging in professional organizations and networking opportunities. Requirements: 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 activities. 3+ years leading teams, ideally in a quality manufacturing environment with proven experience with Good Manufacturing Practices. 2+ years experience with statistical tools, data analysis, SPC, MSA, GR&R, process validation, IQ/OQ/PQ, and root cause analysis. Core Competencies: Regulatory Quality Leadership: Ability to interpret quality system requirements, maintain audit-ready processes, and guide site compliance in a regulated manufacturing environment. Manufacturing Quality Problem Solving: Strong ability to investigate issues, analyze process variation, identify root cause, and drive practical corrective actions that improve product quality and process performance. Cross-Functional Execution: Ability to work effectively across Quality, Operations, Engineering, Purchasing, and leadership teams to align priorities, resolve issues, and support production and NPI needs. Team Leadership & Quality Culture: Ability to lead cross-functional teams, drive issue resolution, train, coach, and hold quality team members accountable while reinforcing a culture of compliance, ownership, and continuous improvement. Quality Systems, Data & Reporting Tools: Proficient in Microsoft Office and able to use quality data, documentation, reports, metrics, and system tools to track performance, support audits, manage corrective actions, and communicate quality trends to leadership. Preferences: Advanced degree, Engineering degree, or another technical field. Experience working in Master Control QMS System Continuous quality improvement experience in one or more medical product environments. Experience working within an ISO 13485 quality management system, including medical device documentation, audit readiness, CAPA, and regulatory compliance. Experience in silicone or rubber molding, including LSR, compression, or transfer molding. Experience supporting medical device OEM customers. Familiarity with FDA 21 CFR 820 and risk management, including ISO 14971. Travel and Work Arrangements Position based onsite in Chicago, IL Work Authorization: US Citizen or Permanent Resident Pay Range The base pay range for this role is $80-110k annually. The pay range considers a wide range of factors that include a candidate’s skills; experience and training; licensure and certifications; and geographic location. What We Offer At Ingersoll Rand, we embrace a culture of personal ownership — taking responsibility for our company, our communities, and our environment, as well as our individual health and well-being. Our comprehensive benefits package is designed to empower you with the tools and support necessary to take charge of your health, ensuring that together, we can continue to make life better. Our range of benefits includes health care options like medical and prescription plans, dental and vision coverage, as well as wellness programs. Additionally, we provide life insurance, a robust 401(k) plan, paid time off, and even an employee stock grant, among other offerings. These benefits are our commitment to you, so you can be your best at work and beyond. Ingersoll Rand Inc. (NYSE:IR), driven by an entrepreneurial spirit and ownership mindset, is dedicated to helping make life better for our employees, customers and communities. Customers lean on us for our technology-driven excellence in mission-critical flow creation and industrial solutions across 40+ respected brands where our products and services excel in the most complex and harsh conditions. Our employees develop customers for life through their daily commitment to expertise, productivity and efficiency. For more information, visit What We Offer At Ingersoll Rand, we embrace a culture of personal ownership — taking responsibility for our company, our communities, and our environment, as well as our individual health and well-being. Our comprehensive benefits package is designed to empower you with the tools and support necessary to take charge of your health, ensuring that together, we can continue to make life better. Our range of benefits includes health care options like medical and prescription plans, dental and vision coverage, as well as wellness programs. Additionally, we provide life insurance, a robust 401(k) plan, paid time off, and even an employee stock grant, among other offerings. These benefits are our commitment to you, so you can be your best at work and beyond. Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are 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. #J-18808-Ljbffr Ingersoll Rand