IT Quality Systems & Compliance Manager

ICU Medical Inc; Hartford (CT); On-site; USD 120,000 - 160,000; Full time

Job summary

ICU Medical seeks a Manager of IT Assurance and Compliance to lead the IT Quality Compliance program, oversee audits, and ensure QMS alignment with regulatory standards. You will drive continuous improvement using automation, analytics, and emerging tech to enhance quality and efficiency across the organization.

The role requires deep expertise in CSA, SQM, 21 CFR Part 11, and cross-functional leadership to guide teams and ensure regulatory readiness.

Qualifications

• Bachelor's degree in sciences, engineering, IT, or related technical field.
• 10+ years of direct IT quality assurance, compliance, and regulatory environments experience (medical devices, life sciences, etc.).
• Experience with FDA inspections, notified body audits, and global/multi-site quality systems.
• Hands-on experience with software validation/testing in regulated environments.
• Experience managing lifecycle and test management tools.
• Experience working in Scrum/Agile environments and with systems integrations/data migration.

Responsibilities

• Lead the enterprise IT Quality Systems Assurance and Compliance program, including internal and external audits.
• Interpret and apply government regulations and standards to the IT QMS.
• Identify, elevate, and address IT compliance risks across the organization.
• Provide compliance training and guidance to IT and business teams globally.
• Create, revise and maintain SOPs to adapt to regulatory requirements and industry best practices.
• Support internal and external audit programs and corrective action development.
• Lead deployment of scalable IT assurance processes and automate where possible.
• Manage lifecycle and test management tools to support CSA and SQM.
• Maintain validated state of computerized systems through change control and inventory.
• Drive continuous improvement with automation, analytics, and data-driven reporting.
• Lead, mentor, and develop IT assurance and compliance team members.
• Collaborate with vendors for IT supplier quality audits and evaluations.

Skills

IT quality assurance

Regulatory compliance

Audit management

SOX compliance

GxP

GAMP 5

Education

Bachelor's degree in sciences/engineering/IT or related field

Tools

Word

PowerPoint

Excel

Visio

eQMS

Smartsheet

Job description

ICU Medical seeks a Manager of IT Assurance and Compliance to lead the IT Quality Compliance program, oversee audits, and ensure QMS alignment with regulatory standards. You will drive continuous improvement using automation, analytics, and emerging tech to enhance quality and efficiency across the organization.

The role requires deep expertise in CSA, SQM, 21 CFR Part 11, and cross-functional leadership to guide teams and ensure regulatory readiness.