Specialist II, Quality

The Specialist II, Quality will primarily support activities related to document and record control, including periodic review, retention, storage, and change control. This role will manage change request packages through the change management process, ensuring draft documents and records meet formatting standards and quality requirements. Additionally, the Specialist will provide support for internal and external audits and other quality-related initiatives.

Position Summary The Specialist II, Quality will primarily support activities related to document and record control, including periodic review, retention, storage, and change control. This role will manage change request packages through the change management process, ensuring draft documents and records meet formatting standards and quality requirements. Additionally, the Specialist will provide support for internal and external audits and other quality-related initiatives.

This role is 100% onsite at our Salt Lake City, UT facility.

• Create and process document change requests, including conducting document searches and reviewing redline documents to ensure compliance with Quality standards
• Collaborate with authors to address issues with incorrect or unclear change records or documents and provide clear guidance for resolution
• Create project or status tracking reports, as requested
• Initiate periodic document review as required
• Perform documentation-related information searches using computerized systems
• Participate in process improvement efforts
• Participate in meetings and activities supporting quality related changes for procedures, work instructions and/or processes related to document and record controls
• Provide troubleshooting and training support to employees
• Provide support for external audits as needed
• Assist with internal audit activities and record closure as required
• Perform special assignments as requested

• Understanding of product structure and role of product specifications, drawings, bills of material, and general procedures (preferred)
• Previous experience supporting documentation systems (preferred)
• Demonstrates exceptional attention to detail and accuracy
• Proficiency using Microsoft Word, Excel, and Adobe Acrobat Professional
• Familiarity with cGMP, FDA, and guidelines governing medical devices
• Strong organizational, communication (verbal and written), and interpersonal skills
• Self-starter with a high level of motivation and a hands-on approach
• Capable of working independently and collaboratively in a multidisciplinary team

• Must be 18 years of age
• Bachelor’s Degree from an accredited college or university
• 2 - 4 years of experience required, preferably in a regulatory, quality or compliance position
• Experience in document and record control preferred

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets.
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time.
• Must be able to occasionally move and lift objects of up to 25 pounds.
• Typically requires travel less than 5% of the time.

ICU Medical has consistently provided clinical innovations that help solve real-world challenges. With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We are Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You

• Dedicated and non-dedicated IV sets and needle free connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and…