Senior Quality Engineer - Medical Devices & NPI Leader

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

Benefits offered by this job

Health care options

401(k) plan

Paid time off

Employee stock grant

Job summary

Ingersoll Rand is seeking a Sr. Quality Engineer in Lincolnshire, IL to ensure compliance with QMS and regulatory requirements in a medical device manufacturing environment.

You will drive validation, CAPA, audits, risk assessments, and cross‑functional collaboration to improve manufacturing and quality processes. This role provides leadership to the quality team, supports new product introductions, and engages with auditors during inspections.

Qualifications

• 5+ years in Quality Engineering within medical devices.
• 3+ years in process improvement methodologies and technical writing.
• 3+ years leading new product introductions with quality focus.

Responsibilities

• Co-manage New Product Introduction with compliant documentation.
• Support change control and revalidation procedures.
• Review and approve validation protocols and reports.
• Lead root cause analyses and CAPA implementation.
• Oversee supplier and internal audits, FDA/ISO readiness.
• Mentor junior quality staff and maintain QMS.
• Report key quality metrics to management.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA

Education

BA/ BS in Engineering or related field

Job description

Ingersoll Rand is seeking a Sr. Quality Engineer in Lincolnshire, IL to ensure compliance with QMS and regulatory requirements in a medical device manufacturing environment.

You will drive validation, CAPA, audits, risk assessments, and cross‑functional collaboration to improve manufacturing and quality processes. This role provides leadership to the quality team, supports new product introductions, and engages with auditors during inspections.