Quality Engineer

Quality Engineer

Job Overview:

The Quality Engineer (QE) ensures that products, manufacturing processes, and Quality Management System (QMS) activities meet established quality standards and regulatory requirements. This role combines technical quality engineering with ownership of key QMS processes, including document control, training, record management, and audit readiness. The QE works cross-functionally with Engineering, Manufacturing, and other teams to support New Product Introduction (NPI) and sustaining operations, ensuring timely execution of validation, risk management, and quality deliverables. The role is also responsible for investigating and resolving nonconformances through CAPA, driving continuous improvement, and supporting the effectiveness of the electronic QMS (e.g., MasterControl) to ensure data integrity and efficient processes.

Responsibilities

• Own and maintain the Quality Management System (QMS), including document control, change management, quality records, electronic QMS (e.g., MasterControl), and training, ensuring compliance with FDA, ISO, and internal requirements.
• Review and approve change controls; oversee calibration and equipment control programs; and drive continuous improvement of QMS processes and systems.
• Support New Product Introduction (NPI) by ensuring compliance with validation (IQ / OQ / PQ), risk management, statistical analysis, customer specifications, and regulatory requirements.
• Partner with Engineering to support sustaining manufacturing, change control, equipment maintenance, revalidation, and process improvement initiatives.
• Perform Device History Record (DHR) reviews; lead or support investigations for nonconformances and CAPAs; and drive root cause analysis, corrective actions, and right-first-time improvements.
• Lead risk management activities, including risk assessments and pFMEA, and ensure effective mitigation strategies.
• Lead and support internal, customer, ISO, and FDA audits; represent Quality in customer and supplier interactions; and support supplier qualification and performance monitoring.
• Support cross-functional and cross-site quality initiatives, special projects, and foster a culture of quality, compliance, continuous improvement, and proactive risk management.

Requirements

• Bachelor's degree (BA/BS) in Engineering, Quality, Life Sciences, or a related technical field
• 1+ years of experience in Quality Engineering, Quality Systems, or a similar role within a medical device or regulated manufacturing environment

Preference:

• Working knowledge of Quality Management Systems (QMS), including document control, training systems, record retention, and audit support
• Familiarity with FDA 21 CFR Part 820 and ISO 13485

Requirements

• Experience with electronic Quality Management Systems (eQMS) such as MasterControl or similar preferred
• Strong technical writing and documentation skills, including development and revision of SOPs, work instructions, validation documents, and quality records
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Lead Auditor Certification is an advantage
• Travel & Work Arrangements/Requirements: Fully site based, flexible working, hybrid, 50% travel across Europe, etc

Pay Range:

• The pay range for this role is $65,000-$80,000. 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 IRCO.com.