Senior Quality Manager - ISO 13485 & FDA Audits

Ingersoll Rand; Lincolnshire (IL); On-site; USD 100,000 - 150,000; Full time

Job summary

Ingersoll Rand Lincolnshire site in Illinois is seeking a Quality Manager to lead the Quality Management System, ensuring products meet quality specifications and regulatory requirements. You will supervise QA and QC staff, drive CAPAs, audits, and continuous improvement initiatives across the site.

The role requires 8+ years in quality assurance and quality control, with experience leading diverse teams and working in highly regulated environments.

Qualifications

• 8+ years minimum overall experience in quality assurance and quality control
• 1+ years of experience leading and managing a large QA/QC team
• 1+ years of experience with ISO 13485, FDA 21CFR820, and Good Manufacturing Practices
• Experience in medical device or highly regulated environments is preferred

Responsibilities

• Develop, maintain, and improve quality procedures and report quality issues
• Oversee ISO quality system requirements and drive continual improvements
• Lead CAPAs, internal/external audits, and supplier audits as needed
• Ensure document and revision control to meet QMS compliance
• Collaborate with Purchasing to evaluate suppliers and maintain product quality

Skills

Quality assurance

Quality control

Leadership

Communication

Regulatory compliance

Education

Bachelor's degree or equivalent

Quality/Mechanical/Industrial engineering degree preferred

Tools

ISO 13485

FDA 21CFR820

GMP

Job description

Ingersoll Rand Lincolnshire site in Illinois is seeking a Quality Manager to lead the Quality Management System, ensuring products meet quality specifications and regulatory requirements. You will supervise QA and QC staff, drive CAPAs, audits, and continuous improvement initiatives across the site.

The role requires 8+ years in quality assurance and quality control, with experience leading diverse teams and working in highly regulated environments.