ICU Medical · 2 weeks ago
Analyst, IT Assurance QMS Applications
United States
Full-time
Remote
Mid Level
4+ years expICU Medical is a global market leader in IV therapy and critical care products. The IT Assurance Analyst provides CSV/Assurance support for computerized systems and collaborates with stakeholders to ensure compliance with quality and regulatory standards.
HealthcareMedical DeviceHealth Care
No H1B
Responsibilities
Work with stakeholders to coordinate and support task execution across projects, sprints, enhancements, and incident‑related work
Support assurance documentation per SOP (e.g., requirements, assessments, deviations, assurance plans, protocols, reports), ensuring strategies and deliverable are complete, well thought out, and aligned with assurance procedures, guidelines, external regulatory requirements, cGMP, GDocP standards, and European and International standards
Interact with QA, IT, Engineering and business area users to understand and identify assurance documentation content for computer system testing with emphasis on capturing appropriate system test scenarios, test cases and business requirements in testing tool
Execute and coordinate revalidation of computer systems
Assess systems and take actions for periodic review per SOP criteria
Review and provide feedback to plant and corporate authors on CSV guidelines, Standard Operating Procedures and policies
Develop and maintain a thorough working knowledge of the ICU Medical Systems assurance requirements
Evaluate routine activities to recommend and support process efficiency enhancements
Perform other related duties as assigned or required, including extended work schedules when required to meet deadlines
Qualification
Required
Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field from an accredited college or university
4+ years of experience in Computer System Validation/ testing in one of the following – Manufacturing, Lab/Facilities, Pharma/Solution processes, Sterilization, Controls systems
Experience in ERP systems development, change, implementation, and lifecycle management – preference to Oracle EBS and Agile applications
Working knowledge of Oracle Agile PLM and Oracle EBS
Experience and functional knowledge of Good Automated Manufacturing Practice (GAMP), cGMP, SDLC, Risk Assessment, EU Annex 11, ISO 13485 and/or 21 CFR Part 11 Electronic Records and Electronic Signatures
Good organizational, presentation, meeting facilitation, and technical writing skills
Attention to details and the ability to proofread and audit validation documents
Ability to collaborate and communicate with a variety of key stakeholders (IT, Manufacturing, Quality, Supply Chain, Logistics, Finance, Internal Audit)
Familiarity with regulatory requirements related to 21 CFRs - Part 11, 820, 210/211, EU Annex 11 and ERES/ Data Integrity requirements
Experience working with SOX, Data Privacy and Security requirements
Resourcefulness and problem‑solving skills, with the ability to navigate identify inefficiencies and ambiguity, remove obstacles, and deliver outcomes through innovative, forward‑thinking planning
Demonstrable experience of working well in a dynamic, demanding environment with minimal supervision and high resourcefulness
Demonstrable experience in balancing multiple priorities and delivering timely, high-quality outcomes
Preferred
Working knowledge of data migration and sampling methods
Process improvement training
Familiarity with automation tools
Familiarity with Test Management tool (e.g., ValidationMaster), MS Excel and/or SQL queries
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
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