Overview
Quality Assurance Accessibility Specialist-System Office Shared Services (Hybrid) Jobs in Urbana, IL at University of Illinois Urbana-Champaign
Summary
In the role of QA/RA Manager for ISO13485 and FDA Medical Devices, you will oversee quality assurance and regulatory compliance within the organization. Reporting to senior management, your core responsibilities will include conducting quality audits, managing quality systems, and ensuring adherence to FDA regulations and ISO 13485 standards. Your premium skills in quality control and analysis will be essential in maintaining high manufacturing standards. Additionally, proficiency in computer skills, particularly Microsoft Excel, will support data collection and analysis efforts.
Join our small family run operation and receive 401k and health care benefits, with the added ability to set a hybrid schedule when available.
Responsibilities:
Management representative for QMS as defined in ISO 13485
Document control coordinator
Corrective Action Coordinator
Work with other team members to handle, document, and resolve Customer Complaints and corrective actions related to the complaints.
Work with organization to resolve issues and non-conformances
Conduct production and final inspections when needed
CORE Compliance Platform Administrator
Facilitate and Manage the Management Review
Manage Internal Audits with External Auditor
Participate in Risk Assessment documentation
Lead representative during ISO Audit and Certification
Handle training and training documentation for QMS related subjects
Perform Data collection and analysis on Objective and KPI, Complaints, Process Performance to determine improvements to System Health
Monitor and update any changes in ISO 13485 Regulations and identify impacts to systems.
Provide support and participation in other organizational roles and tasks as needed.
Qualifications:
Knowledge and experience with both ISO13485 and FDA MedDev Regulations, Eg. 21CFR820
Computer skills, Excel, Word, Microsoft Windows
Job Types: Full-time, Permanent
Pay: $99,287.00 – $108,135.00 per year
Benefits:
401(k)
401(k) matching
Health insurance
Work Location: Hybrid remote in Jersey City, NJ 07307
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Title: Quality Assurance Accessibility Specialist-System Office Shared Services (Hybrid)
Company: University of Illinois Urbana-Champaign
Location: Urbana, IL
