Remote IT Quality Assurance and Compliance Leader

ICU Medical Inc; Austin (TX); On-site; USD 130,000 - 160,000; Full time

Job summary

ICU Medical is seeking a Manager of IT Assurance and Compliance to oversee global IT Quality Systems, CSA, SQM, and regulatory compliance programs. You will lead audits, drive continuous improvement, and partner with cross-functional teams to ensure validated, compliant systems across the organization.

The role emphasizes leveraging automation, analytics, and emerging technologies to enhance quality and efficiency, with remote work flexibility and global touchpoints across sites and functions.

Qualifications

• Expert knowledge of IT quality and regulatory disciplines (21 CFR, Annex 11, SOX, PCI, ISO 13485).
• Advanced understanding of CSA, systems validation, risk-based validation (GAMP 5) and GDocP.
• Experience leading internal and external audit programs.
• Strong organization, time management and project management skills.
• Excellent written, verbal and interpersonal communication skills.

Responsibilities

• Lead the enterprise IT Quality Systems Assurance and Compliance program, including audits.
• Interpret and apply government regulations to the IT QMS.
• Identify IT compliance risks and address them globally.
• Provide compliance training and guidance to IT and business teams.
• Create, revise and maintain SOPs to meet regulatory requirements.

Skills

IT quality assurance

Regulatory disciplines

Audit leadership

Project management

Communication skills

Software tools

Education

Bachelor's degree in sciences/engineering/IT

Tools

eQMS

Smartsheet

Visio

Word/PowerPoint

Job description

ICU Medical is seeking a Manager of IT Assurance and Compliance to oversee global IT Quality Systems, CSA, SQM, and regulatory compliance programs. You will lead audits, drive continuous improvement, and partner with cross-functional teams to ensure validated, compliant systems across the organization.

The role emphasizes leveraging automation, analytics, and emerging technologies to enhance quality and efficiency, with remote work flexibility and global touchpoints across sites and functions.