Sr. Quality Systems Specialist - Industrial Affairs
Core
Manage quality systems, regulatory documentation, animal origin compliance, and customer quality support for global import/export activities in a regulated, high-volume testing environment.
Role type
Senior Quality Systems Specialist (Industrial Affairs)
Builds
Regulatory readiness, supply continuity, and product compliance for global customers and government agencies.
Domain
Life Sciences / Medical Technology / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Animal origin compliance, regulatory interpretation, CAPA management, data analysis, audit support, supplier documentation, traceability management, quality metrics creation, training and mentoring, cross-functional collaboration
Preferred skills
None stated
Technologies
Enterprise systems, complex databases
Responsibilities
Manage and maintain animal origin quality systems, specifications, databases, certifications, and traceability documentation; Develop, review, and maintain Quality System procedures and technical documentation related to animal and non-animal origin controls; Investigate issues, analyze data, and implement solutions related to quality systems, supplier management, CAPA, training, product support, vigilance, and recall activities; Collect, review, trend, and analyze quality data using enterprise systems and complex databases to support quality and business objectives; Respond directly to customer quality and regulatory inquiries, providing accurate and timely documentation; Host and manage customer audits and support audit readiness activities; Train and mentor associates within and outside of Industrial Affairs; Lead or coordinate quality-system-related initiatives with minimal supervision.
Seniority
Senior, hands-on IC with potential supervisory responsibilities