Quality Systems Specialist
Core
Maintain and continuously improve the Quality Management System (QMS) for life sciences diagnostics and biotechnology products, ensuring compliance with ISO 9001, ISO 13485, and FDA regulations.
Role type
Quality Systems Specialist
Builds
Compliant QMS processes, audit readiness, and quality metrics dashboards
Domain
Life sciences / Diagnostics / Biotechnology / Regulatory Quality
Deliverable
dashboards & analysis
Required skills
QMS process maintenance, audit support (internal/external), CAPA management, document control, eQMS administration, quality metrics analysis, regulatory compliance (ISO 9001/13485/FDA)
Preferred skills
Non-product software validation, AI applications, Power BI, statistical tools, internal auditor training
Technologies
eQMS, Power BI
Responsibilities
Support internal and external audit planning, readiness, execution, and action-item closure; Administer eQMS activities including document changes and training assignments; Guide audit NC and CAPA owners through investigations and effectiveness verification; Monitor quality metrics and maintain dashboards to identify improvement opportunities; Support non-product software validation and cross-functional QMS improvement projects.
Seniority
Mid-level, hands-on IC