Sr. Quality Engineer

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Sr.Quality Engineer

Lincolnshire, IL

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 t o 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 Senior Quality Engineer is responsible for ensuring compliance with Quality Management System (QMS) and applicable regulatory requirements within our medical device manufacturing environment. This role encompasses a wide range of responsibilities, including validation activities,process improvements, nonconformance and CAPA management, auditing responsibilities, risk assessments, and training initiatives. The Senior Quality Engineer also collaborates across departments to enhancecurrentmanufacturing/quality processes and supports new product introductions.

The Senior Quality Engineer is expected to provide guidance and leadership toother members of the quality department, including Document Technicians, Quality Inspectors, and Quality Engineers.

Co-managethe New Product Introduction (NPI) process by ensuring compliance with necessary documentation such as checklists, validation protocols, validation reports, statistical analyses, customer specifications, and relevant ISO documents. Assist engineering teams with sustaining manufacturing projects by ensuring compliance with change control, tooland equipment maintenance, and revalidation procedures. Review and approve engineering documentation, including validation protocols/reports, sample run requests, and manufacturing procedures, ensuring adherence to customer and regulatory requirements.

Develop procedures and work instructions to streamline processes ncompliance with FDA regulations, ISO standards, and other applicable regulatory requirements. Reviewand approve change requests, ensuring proper evaluation of the impact on product quality, processes,and regulatory compliance. Leadthe resolution of internal and externalnonconformances by performing root cause analysis and implementing corrective and preventive actions. Oversee the investigation of product complaints, ensuring timely resolution and appropriate reporting.

Represent Flexan effectively during customer and supplier meetings. Complete customer surveys and requests in a timely manner. Contribute to the Supplier Management Programbyassessing newand existing suppliers, managing the approved supplier list, and other related tasks. Manages change requests submitted to customers through completion. Provide expertise on environmental and cleanroom requirements, ensuring compliance with relevant guidelines. Evaluate new technologies and tools for potential integration into processes to enhance efficiency.

Monitorkey quality metrics and provide regular reports to management. Leadrisk management activities by conducting risk assessments and pFMEAssessions, as required Collaborate with cross-functional teams to identify equipment, testing, and resource needs, effectively communicating these to management. Host or co-host customer and ISO…