Senior IT Quality & Compliance Manager (Remote)

ICU Medical Inc; Lansing (MI); On-site; USD 130,000 - 165,000; Full time

Job summary

ICU Medical is seeking a Manager of IT Assurance and Compliance to lead the IT Quality Compliance program across the organization. The role ensures alignment with global quality systems, administers audits, and guides teams on IT compliance risks.

You will drive continuous improvement using automation and analytics, manage validation and change control, and partner with IT and business units to maintain compliant systems.

Qualifications

• Bachelor's degree in sciences, engineering, IT, or related field.
• 10+ years of IT quality assurance, compliance, and regulatory experience in regulated environments.

Responsibilities

• Lead enterprise IT Quality Systems Assurance and Compliance program, including audits.
• Interpret and apply regulations to the IT QMS (21 CFR Part 11, Annex 11, SOX).
• Identify IT compliance risks and provide guidance globally.
• Support audits, inspections (FDA, ISO 13485, MDSAP).
• Drive continuous improvement with automation, analytics, and testing tools.

Skills

IT quality assurance

Regulatory compliance

Audit management

Project management

Training and guidance

Analytical thinking

Communication

Team leadership

Automation & analytics

GxP and SOX knowledge

Education

Bachelor's degree in sciences/engineering/IT

Tools

eQMS

Smartsheet

Visio

Microsoft 365 (Word, PowerPoint, Excel)

Job description

ICU Medical is seeking a Manager of IT Assurance and Compliance to lead the IT Quality Compliance program across the organization. The role ensures alignment with global quality systems, administers audits, and guides teams on IT compliance risks.

You will drive continuous improvement using automation and analytics, manage validation and change control, and partner with IT and business units to maintain compliant systems.