Senior Quality Systems Engineer
Core
Provide technical leadership and subject matter expertise in the development, maintenance, and continuous improvement of the Quality Management System (QMS) to ensure compliance with regulatory requirements and industry standards.
Role type
Senior Quality Systems Engineer
Builds
Quality Management System (QMS) processes, documentation, and compliance frameworks
Domain
Medical device manufacturing / Regulatory compliance
Deliverable
dashboards & analysis
Required skills
QMS process management, CAPA management, root-cause analysis, audit support, regulatory compliance analysis, risk-based decision-making, technical writing, cross-functional partnership
Responsibilities
Lead and support QMS processes including CAPA, nonconforming events, internal audits, external audits and management review; Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, and EU MDR; Mentor teams leading complex investigations and corrective actions; Support internal and external audits and regulatory inspections; Analyze quality metrics and trends to identify systemic risks; Lead continuous improvement initiatives; Partner cross-functionally to resolve quality issues; Develop and maintain quality procedures and controlled documentation; Serve as a QMS subject matter expert providing guidance and training; Lead quality-system projects; Partner with Global teams to drive continual improvement.
