ICU Medical · 19 hours ago
Specialist, QA
Salt Lake City, UT
Full-time
Onsite
Entry, Mid Level
2+ years expICU Medical, Inc. is a company specializing in medical devices, and they are seeking a Quality Assurance Specialist to ensure compliance with their Quality System. The role involves coordinating quality administration activities, supporting quality engineers, and maintaining data integrity while ensuring adherence to regulatory requirements.
Health CareMedical Device
Responsibilities
Act as an NCMR-B, CAPA and SCARs Coordinator for SLC site
Collect, analyze and file non-conforming product samples for NCMR-B reviews
Coordinate bracketing and containment activities of non-conforming materials
Support quality engineers and management with product investigations, collection and analysis of data, etc
Work with various inspection equipment such as gages, calipers, etc. to perform sample analysis
Collaborate with internal teams such as materials, QA, FQA, Engineering, Validation Lab, etc
Perform activities towards creation, disposition and closure of NCMRs
Coordinate with internal stake holders, sister facilities and external vendors/suppliers as per direction from quality engineering and management towards resolution of quality issues
Coordinate shipment of non-conforming or build at risk materials between sister facilities
May assist FQA with resolution of any compliance issues related to NCMR materials, associated work orders etc
Ensure compliance of CAPA system. Performs CAPA coordination activities via weekly/monthly CRB reviews and working with CAPA owners to establish action plans etc
Create presentations for CAPA & SCAR Review Boards; run daily NCMR-B, management reviews etc
Ensure clean data via implementation of quality at source with regards to data accuracy
Perform monthly tracking & trending of various quality metrics and deliver to local & global teams
Perform automation of data and improve the systems to reduce manual work and redundancies
Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations
Conduct in-process inspections and internal audits to ensure compliance with regulatory requirements (ISO 13485, 21CFR820 etc.), and internal standard operating procedures
Trains QA personnel on GMPs, defects, best practices etc
Assist with internal quality system audits
Evaluates and addresses deficiencies for potential impact on product compliance status
Maintains a controlled documentation system including Quality System data and records
Create action plans, project plans or road maps and provide regular updates to site leadership
Collaborate and communicate effectively across various levels and geographies of the organization
Drive compliance and completion of activities in a timely fashion
Participate in meeting departmental goals and objectives
Conduct safety inspections and take prompt action to eliminate work hazards
Performs other professional related duties as assigned or required
Qualification
Required
Ability to independently exercise sound judgment for defined job duties, obtain results, troubleshoot problems, and formulate solutions
Self-starter, highly motivated, and hands-on
High attention to detail and accuracy
Ability to manage multiple tasks
Proven ability to work effectively alone and in a multi-disciplinary team
Works collaboratively with staff at all levels, to advance quality improvement efforts and promoting a culture of quality, continuous improvement, responsibility, and mutual respect
Experience with tools such as Power BI, MS Excel, Word, Power Point, Macros, Visual Basic Programming etc. for automation of data analysis
Excellent communication and collaboration skills
Follows regulations, norms and procedures. Promptly responds to customer's requests / customer focus
Must be at least 18 years of age
2-4 years prior experience in the medical devices or other regulated industries or manufacturing setting
Four-year degree in science or quality-related fields. Other credentials may be considered
Ability to understand and implement cGMP, or ISO 13485 Quality Management System Requirements
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