Site Quality Lead

Site Quality Lead

Site Quality Lead

BH Job

SF Job Req

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:

Site Quality 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  and join us to own your future.

Job Overview:

Step into a visible, hands-on quality leadership role where your work directly impacts product integrity, customer confidence, and manufacturing performance. The Site Quality 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…