Document Controller
Core
Own and coordinate document control and change control activities within an electronic Quality Management System (eQMS) for medical device and pharmaceutical partners.
Role type
Quality Management System (eQMS) Document Controller
Builds
Controlled quality documentation, change control records, and training matrices for regulatory compliance.
Domain
Medical device and pharmaceutical quality management
Required skills
Document control, change control, regulatory compliance (ISO 13485, FDA 21 CFR Part 820), eQMS management, risk assessment, training coordination
Preferred skills
EU MDR 2017/745, EU IVDR 2017/746, ISO 14971, Science or Engineering degree
Technologies
eQMS
Responsibilities
Coordinate document control and change control activities, review document submissions for accuracy, organize change control review meetings, maintain training matrices, deliver QMS induction training, maintain quality records, escalate compliance risks
Seniority
Junior to Mid-level, hands-on IC
