Quality & Regulatory Specialist
Core
Coordinate customer quality concerns and corrective/preventive actions (CAPA) across multiple manufacturing sites to ensure consistent, high-quality responses and regulatory compliance.
Role type
Quality & Regulatory Specialist (Administrative/Coordination)
Builds
Standardized quality response processes and auditable records for customer quality issues
Domain
Manufacturing / Quality Management Systems
Deliverable
dashboards & analysis
Required skills
CAPA process management, cross-site coordination, regulatory compliance documentation, audit support, data tracking, report compilation, multi-site communication
Preferred skills
Quality management systems familiarity, customer complaint handling, manufacturing environment experience, continuous improvement mindset
Technologies
Standard office software, reporting tools
Responsibilities
Receive, document, and track customer quality concerns from initiation to resolution; Support Quality Managers in executing CAPA by gathering data and coordinating resources; Monitor CAPA progress to ensure timeliness and effectiveness; Facilitate cross-site meetings to align corrective actions and share best practices; Prepare and distribute regulatory compliance reports; Maintain accurate and auditable records of quality actions and outcomes.
Seniority
Individual Contributor, mid-level coordination