Senior Quality Engineer - Medical Devices, NPI & Compliance

Ingersoll Rand; Lincolnshire (IL); On-site; USD 80,000 - 120,000; Full time

Job summary

Ingersoll Rand is seeking a Senior Quality Engineer in Lincolnshire, IL to ensure QMS and regulatory compliance within a medical device manufacturing environment. You will drive validation activities, CAPA, audits, risk assessments, and cross-functional collaboration to improve manufacturing and support new product introductions.

You will provide leadership across the quality team, including Document Technicians and Quality Engineers, and partner with suppliers and customers to maintain top

Qualifications

• 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.

Responsibilities

• Co-manage the New Product Introduction (NPI) process with required documentation (checklists, validation protocols/reports, analyses).
• Assist engineering teams with sustaining manufacturing projects, ensuring change control and maintenance procedures.
• Review/approve validation protocols/reports, sample run requests, and manufacturing procedures for compliance.
• Develop procedures and work instructions to streamline processes and FDA/ISO compliance.
• Lead investigations of nonconformances and implement corrective actions.
• Oversee product complaint investigations and reporting.
• Host or co-host customer and ISO audits and FDA inspections.

Skills

Quality Engineering

Regulatory Compliance

CAPA management

Root cause analysis

NPI process

Change control

FDA inspections

ISO audits

Education

BA/BS in Engineering or related field

Job description

Ingersoll Rand is seeking a Senior Quality Engineer in Lincolnshire, IL to ensure QMS and regulatory compliance within a medical device manufacturing environment. You will drive validation activities, CAPA, audits, risk assessments, and cross-functional collaboration to improve manufacturing and support new product introductions.

You will provide leadership across the quality team, including Document Technicians and Quality Engineers, and partner with suppliers and customers to maintain top