Sr. Quality Engineer - NPI

Salt Lake City, Utah, United States

• Category: Quality Engineering

Description

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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. 

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:
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) and sustaining manufacturing processes by ensuring compliance with required documentation, validations, customer specifications, ISO standards, and regulatory requirements.
• Review, approve, and manage engineering and change-control documentation, including validation protocols/reports, manufacturing procedures, sample requests, and customer change submissions through completion.
• Develop, maintain, and improve procedures, work instructions, and QMS documentation in compliance with FDA regulations, ISO standards, and applicable environmental and cleanroom requirements.
• Lead risk management, nonconformance resolution, and CAPA activities, including root cause analysis, pFMEAs, complaint investigations, and corrective/preventive action implementation.
• Monitor, analyze, and report key quality metrics, providing regular updates to management and driving continuous improvement initiatives.
• Support and lead customer, supplier, ISO, and FDA audits and inspections, ensuring audit readiness and effective representation of Flexan.
• Contribute to the Supplier Management Program, including supplier assessments, approved supplier list maintenance, customer surveys, and supplier/customer engagement.
• Promote a strong culture of quality by collaborating cross-functionally, delivering employee training, supporting the Quality Manager, and serving as a backup for key quality functions as needed.

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.

Preferences:

• Robust knowledge of Failure Mode Effects Analysis (FMEA) and Production Part Approval Process (PPAP)
• Strong technical writing skills
• Experience with supplier quality functions, including management of approved vendor lists 
• Demonstrated experience in process improvement methodologies.
• Active involvement in FDA and ISO audits, with a strong understanding of regulatory compliance requirements.
• Detailed knowledge of FDA 21 CFR 820, ISO 13485, and ISO 14644-1.
• Strong analytical skills with emphasis on statistical/data analysis
• Ability to coach and develop others
• Ability to drive/lead in a matrix structure with persuasion and influence
• Organization and time management skills are essential
• Creativity, verbal and written communication skills, and problem-solving ability
• Team player that gets along well with others (respectful of supervisors and co-workers, helps others by offering ideas when appropriate)
• Follows through on tasks and projects as assigned

Core Competencies:

• Quality
• Accountability
• Respect
• Innovation
• Integrity
• Open & honest communications
• Teamwork
• Customer focus

Travel & Work Arrangements/Requirements:
Onsite

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. 

To Apply:
Please apply via our website https://ir-jobs.dzconnex.com/ by February 2026 in order to be considered for this position. 

Company

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Ingersoll Rand

Ingersoll Rand advances the quality of life by creating comfortable, sustainable and efficient environments.  Our people and our family of brands—including Club Car®, Ingersoll Rand®, Thermo King® and Trane®—work together to enhance the quality and comfort of air in homes and buildings; transport and protect food and perishables; and increase industrial productivity and efficiency. We are a global business committed to a world of sustainable progress and enduring results.

At Ingersoll Rand, we're committed to meeting the world's growing critical need for clean and comfortable air, safe and fresh food, energy efficiency and sustainable business practices. We're passionate about building a better future - a world of sustainable progress and enduring results. 

Our success is enabled by the commitment and dedication of our employees globally.  With our focus on a progressive, diverse and inclusive culture, growth through innovation in emerging markets and services and operational excellence, we are a company that achieves real progress for our customers around the world.

Our workplace emphasizes the values of Integrity, Respect, Teamwork, Innovation and Courage. To help our employees grow, we believe it's vital to strengthen their engagement and develop their skills and leadership capabilities. Our Brand Promise, Vision and Values are the language that unifies us as an organization and creates a common purpose: advancing the quality of life by creating and sustaining safe, comfortable and efficient environments.