Quality Assurance Compliance Specialist I
Core
Support the Quality Assurance Compliance team in maintaining global regulatory compliance and the Quality Management System (QMS) for medical devices.
Role type
Junior IC quality assurance compliance specialist
Builds
Regulatory compliance documentation and audit readiness for medical device products
Domain
Medical device / Regulatory affairs
Deliverable
dashboards & analysis
Required skills
Quality Management System (QMS) maintenance, CAPA process support, internal audit participation, nonconformance tracking, Good Documentation Practices (GDP), UDI data management, regulatory documentation support, training program tracking
Preferred skills
Familiarity with FDA 21 CFR Part 820, ISO 13485, MDR, MDSAP, eQMS platforms, cross-functional collaboration in regulated environments
Technologies
eQMS, GUDID, EUDAMED
Responsibilities
Support maintenance of the Quality Management System (QMS) in compliance with FDA, ISO 13485, and global regulations; Assist with CAPA processes including initiation, investigation, tracking, and verification; Participate in internal audits and support external inspections; Track and close audit nonconformities; Maintain quality documentation per GDP; Support UDI data generation and verification; Assist with training program tracking
Seniority
Entry-level, foundational knowledge