Sr. Quality Engineer

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: Sr.Quality Engineer

Location: Lincolnshire, IL

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 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 irco.com and join us to own your future.

Job Overview:
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 enhance current manufacturing/quality processes and supports new product introductions. The Senior Quality Engineer is expected to provide guidance and leadership to other members of the quality department, including Document Technicians, Quality Inspectors, and Quality Engineers.  

Responsibilities:
Co-manage the 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, tool and 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 n compliance with FDA regulations, ISO standards, and other applicable regulatory requirements.  
Review and approve change requests, ensuring proper evaluation of the impact on product quality, processes, and regulatory compliance. 
Lead the resolution of internal and external nonconformances 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 Program by assessing new and 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. 
Monitor key quality metrics and provide regular reports to management. 
Lead risk management activities by conducting risk assessments and pFMEAs sessions, 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 audits, as well as FDA inspections, ensuring preparedness and compliance. 
Serve as a backup for various quality functions, including Document Technicians and Quality Engineers, as needed. 
Support the Quality Manager in the overall maintenance and monitoring of the Quality Management System (QMS). 
Lead initiatives to improve the Quality Management System and participate in the periodic review of documents.  
Conduct employee training sessions. 
Perform internal and external audits as assigned.  
Assist other business units with projects as assigned. 
Engage with key stakeholders to promote a culture of quality throughout the organization. 

Requirements:

• BA / BS in Engineering or related field. 
• 5+ years of Quality Engineering or similar experience in a medical device manufacturing environment and/or regulated industry. 
• 3+ years of experience in process improvement methodologies and technical writing. 
• 3+ years of success in leading new product introductions with a focus on quality assurance and compliance throughout the development process. 

Core Competencies:

• Active involvement in FDA and ISO audits, with a strong understanding of regulatory compliance requirements. 

Travel & Work Arrangements/Requirements

• Fully on-site

The pay range for this role is $80-$120k, excluding incentive opportunities. The pay range takes into account a wide range of factors that are considered in making compensation decisions including, but not limited to, skills; experience and training; licensure and certifications; and geographic location.  Hired applicant will be eligible to receive (discretionary/nondiscretionary) annual bonuses and incentive compensation.

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 www.IRCO.com.