Quality Specialist
Core
Support the development, implementation, and maintenance of Quality Management System (QMS) processes to ensure compliance with FDA 21 CFR 820 and ISO 13485 requirements.
Role type
Quality Specialist (Medical Device)
Builds
QMS processes and compliance frameworks for MedTech products
Domain
Medical Technology / Regulatory Quality
Required skills
QMS process management, CAPA leadership, root cause analysis, audit support, regulatory compliance (FDA/ISO), data analysis, mentorship
Preferred skills
Regional site leadership, cross-functional project management
Technologies
QMS software, audit tools
Responsibilities
Support QMS processes for FDA 21 CFR 820 and ISO 13485 compliance; Lead CAPA activities including investigation and root cause analysis; Mentor regional teams on QMS requirements; Facilitate Nonconformance Coach meetings; Ensure alignment of regional procedures with global standards; Support internal and external audits; Analyze quality metrics and trend data; Maintain integrity of nonconformance records.
Seniority
Mid-level, hands-on IC