ICU Medical · 3 days ago
Specialist II, Quality
Salt Lake City, UT
Full-time
Onsite
Entry, Mid Level
2+ years expICU Medical is a global market leader in IV therapy and critical care products. The Specialist II, Quality will support document and record control activities, manage change request packages, and provide assistance for internal and external audits related to quality initiatives.
Health CareMedical Device
Responsibilities
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
Qualification
Required
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
Preferred
Understanding of product structure and role of product specifications, drawings, bills of material, and general procedures
Previous experience supporting documentation systems
Experience in document and record control
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase