Specialist II, Quality

ICU Medical•Salt Lake City, UT

7h•Onsite

About The Position

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

Requirements

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
Demonstrates exceptional attention to detail and accuracy
Proficiency using Microsoft Word, Excel, and Adobe Acrobat Professional
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

Nice To Haves

Understanding of product structure and role of product specifications, drawings, bills of material, and general procedures (preferred)
Previous experience supporting documentation systems (preferred)
Familiarity with cGMP, FDA, and guidelines governing medical devices
Experience in document and record control preferred

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